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Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil (Remember)

Primary Purpose

Cognitive Dysfunction, Memory Impairment

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Donepezil 5 mg
Placebo
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Dysfunction focused on measuring Donepezil, Cognition, Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women ≥18 years old with history of invasive breast cancer
  • Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to registration (Ongoing herceptin or other chronic HER 2 directed therapies are allowed).
  • Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and plan to continue for the duration of the study (9 months)
  • Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks. Patients who were previously on one of these psychotropic medications and have subsequently discontinued the drug must have been off the medication for at least 4 weeks prior to enrollment. Patients who have been on a psychotropic medication for at least 12 weeks but have recently switched to a medicine in the same class (for example, switching from one SSRI antidepressant to a different SSRI antidepressant) need to be on a stable dose of the new medication for at least 4 weeks prior to enrollment to be eligible.
  • Self-reported cognitive problem plus a measured memory deficit (score <7 on single trial of Eligibility Pre-screen HVLT-R Form 3).
  • ECOG performance status 0-2
  • Ability to understand and the willingness to sign a written informed consent document.
  • Must be able to speak English.
  • Patients currently taking a moderate risk QTc prolongation medication (see Appendix A) are allowed if one of the following criteria are met: 1) The moderate risk QTc prolongation medication is stopped. The patient should be off the moderate risk QTc prolongation medication for at least 5 half-lives before starting study drug. 2) Patients that continue using a moderate risk QTc prolongation medication must have a normal QTc interval (≤ 460 milliseconds) on a screening ECG following informed consent and prior to study enrollment. These patients will also be monitored at designated study follow-up visits per Section 7.5 (monitored 3-7 days after initiating study drug, at week 3, and 3-7 days after the study drug dose increase with ECG's to assess the QTc interval; the QTc level must be ≤ 500 milliseconds at these time points in order to continue on the study drug). 3) Moderate risk QTc prolongation medications that are only taken occasionally may be stopped at the discretion of the treating site physician. Patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible.
  • Patients currently taking a moderate risk bradycardia-causing agent (see Appendix B) are allowed if one of the following criteria are met: 1) The moderate risk bradycardia-causing agent is stopped. The patient should be off the moderate risk bradycardia-causing agent for at least 5 half-lives before starting study drug. 2) Patients that continue using a moderate risk bradycardia-causing agent must have a resting heart rate ≥ 55 beats per minute at screening following informed consent. These patients' resting heart rate will be monitored 3-7 days after initiating study drug, at week 3, and 3-7 days after the study drug dose increase per Section 7.5. 3) Moderate risk bradycardia-causing agents that are only taken occasionally may be stopped at the discretion of the treating site physician. Patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible.

Exclusion Criteria:

  • Evidence or suspected recurrent or metastatic disease.
  • Prior brain irradiation is not allowed.
  • Planned therapy (surgery, radiation, chemotherapy, or immunotherapy) while on the study for brain and/or extracranial primary/metastatic disease.
  • Hypersensitivity to donepezil or piperidine derivatives
  • Current use of ceritinib
  • Current use of Succinylcholine/Acetylcholinesterase Inhibitors(as listed in Appendix C). For patients who have used these medications, they must not have used them within 4 weeks prior to enrollment.
  • Current use of high-risk QTc prolonging medication(s). See Appendix D
  • Current use of quinidine or systemic ketoconazole (topical ketoconazole is acceptable to use while on study).
  • History of dementia, Alzheimer's disease, multi-infarct dementia or clinically significant Cerebrovascular Accident (history of transient ischemic attack (TIA) is allowed).
  • Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drug(s). For patients who have used these medications, they must not have used them within 4 weeks prior to pre-screening. Patients who plan to start taking a cognition enhancing drug while on this study are also excluded.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to donepezil. Hypersensitivity to donepezil.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia.
  • Major medical conditions that affect cognition, traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia.
  • Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse.
  • Untreated current severe depression. Currently treated depression is permitted if treatment is stable.
  • Patients with a resting heart rate less than 55 beats per minute, seizure disorder or peptic ulcer disease (PUD).
  • History of congenital long QT syndrome or torsades de pointes.
  • Screening QTc of > 460 milliseconds will make the patient ineligible.
  • Pregnant women are excluded from this study. Following informed consent, women of child-bearing potential will be screened with a serum or urine pregnancy test within 10 days of enrollment. The effects of donepezil on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because donepezil is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.
  • It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breast-feeding are not eligible for this study.
  • On another intervention study involving medication at the time of enrollment or during participation in this study. (Exception: Patients will remain eligible for this study if they are also enrolled on the Alliance for Clinical Trials in Oncology study (NCT02927249): Aspirin in Preventing Recurrence of Cancer in Patients with HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy. Studies that involve only blood draws or questionnaires are also permitted.)
  • Use of investigational drugs likely to affect cognition within 30 days prior to pre-screening visit.

Sites / Locations

  • Kaiser Permanente-Anaheim
  • Kaiser Permanente-Deer Valley Medical Center
  • Kaiser Permanente-Baldwin Park
  • Kaiser Permanente-Bellflower
  • Kaiser Permanente-Fontana
  • Kaiser Permanente-Fremont
  • Fresno Cancer Center
  • Kaiser Permanente-Fresno
  • Kaiser Permanente - Harbor City
  • Kaiser Permanente-Irvine
  • Kaiser Permanente Los Angeles Medical Center
  • Kaiser Permanente West Los Angeles
  • Kaiser Permanente-Modesto
  • Kaiser Permanente-Oakland
  • Kaiser Permanente-Ontario
  • Kaiser Permanente - Panorama City
  • Kaiser Permanente-Rancho Cordova Cancer Center
  • Kaiser Permanente-Richmond
  • Kaiser Permanente-Riverside
  • Kaiser Permanente-Roseville
  • The Permanente Medical Group-Roseville Radiation Oncology
  • Kaiser Permanente Downtown Commons
  • Kaiser Permanente-South Sacramento
  • South Sacramento Cancer Center
  • Kaiser Permanente - Sacramento
  • Kaiser Permanente-San Diego Zion
  • Kaiser Permanente-San Francisco
  • Kaiser Permanente-Santa Teresa-San Jose
  • Kaiser Permanente San Leandro
  • Kaiser Permanente-San Marcos
  • Kaiser Permanente-San Rafael
  • Kaiser San Rafael-Gallinas
  • Kaiser Permanente Medical Center - Santa Clara
  • Kaiser Permanente-Santa Rosa
  • Kaiser Permanente-South San Francisco
  • Kaiser Permanente-Stockton
  • Kaiser Permanente Medical Center-Vacaville
  • Kaiser Permanente-Vallejo
  • Kaiser Permanente-Walnut Creek
  • Kaiser Permanente-Woodland Hills
  • Penrose-Saint Francis Healthcare
  • Rocky Mountain Cancer Centers-Penrose
  • Kaiser Permanente-Franklin
  • Porter Adventist Hospital
  • Kaiser Permanente-Rock Creek
  • Littleton Adventist Hospital
  • Kaiser Permanente-Lone Tree
  • Longmont United Hospital
  • Parker Adventist Hospital
  • Helen F Graham Cancer Center
  • Medical Oncology Hematology Consultants PA
  • Christiana Care Health System-Christiana Hospital
  • Beebe Health Campus
  • TidalHealth Nanticoke / Allen Cancer Center
  • Holy Cross Hospital
  • Pali Momi Medical Center
  • Hawaii Cancer Care Inc - Waterfront Plaza
  • Queen's Cancer Cenrer - POB I
  • Queen's Medical Center
  • Straub Clinic and Hospital
  • University of Hawaii Cancer Center
  • Hawaii Cancer Care Inc-Liliha
  • Queen's Cancer Center - Kuakini
  • Kaiser Permanente Moanalua Medical Center
  • Kapiolani Medical Center for Women and Children
  • Saint Luke's Cancer Institute - Boise
  • Saint Luke's Cancer Institute - Fruitland
  • Saint Luke's Cancer Institute - Meridian
  • Saint Luke's Cancer Institute - Nampa
  • Saint Luke's Cancer Institute - Twin Falls
  • Illinois CancerCare-Bloomington
  • Illinois CancerCare-Canton
  • Centralia Oncology Clinic
  • Carle on Vermilion
  • Cancer Care Specialists of Illinois - Decatur
  • Decatur Memorial Hospital
  • Carle Physician Group-Effingham
  • Crossroads Cancer Center
  • Illinois CancerCare-Galesburg
  • Illinois CancerCare-Kewanee Clinic
  • Carle Physician Group-Mattoon/Charleston
  • Illinois CancerCare-Ottawa Clinic
  • Illinois CancerCare-Pekin
  • Illinois CancerCare-Peoria
  • Illinois CancerCare-Peru
  • Carle Cancer Center
  • The Carle Foundation Hospital
  • Physicians' Clinic of Iowa PC
  • Iowa Methodist Medical Center
  • Medical Oncology and Hematology Associates-Des Moines
  • Broadlawns Medical Center
  • Mercy Medical Center - Des Moines
  • Iowa Lutheran Hospital
  • Methodist West Hospital
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas-Kingman
  • Cancer Center of Kansas-Manhattan
  • Cancer Center of Kansas - McPherson
  • Cancer Center of Kansas - Newton
  • Cancer Center of Kansas - Parsons
  • Cancer Center of Kansas - Salina
  • Cancer Center of Kansas - Wellington
  • Associates In Womens Health
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Ascension Via Christi Hospitals Wichita
  • Cancer Center of Kansas - Wichita
  • Cancer Center of Kansas - Winfield
  • Flaget Memorial Hospital
  • Saint Joseph Radiation Oncology Resource Center
  • Saint Joseph Hospital East
  • Saint Joseph London
  • Christus Saint Frances Cabrini Hospital
  • LSU Health Baton Rouge-North Clinic
  • Louisiana Hematology Oncology Associates LLC
  • Mary Bird Perkins Cancer Center
  • Our Lady of the Lake Physicians Group - Medical Oncology
  • Louisiana State University Health Science Center
  • University Medical Center New Orleans
  • Ochsner Medical Center Jefferson
  • CHRISTUS Highland Medical Center
  • Saint Joseph Mercy Hospital
  • IHA Hematology Oncology Consultants-Brighton
  • Saint Joseph Mercy Brighton
  • IHA Hematology Oncology Consultants-Canton
  • Saint Joseph Mercy Canton
  • Caro Cancer Center
  • IHA Hematology Oncology Consultants-Chelsea
  • Saint Joseph Mercy Chelsea
  • Hematology Oncology Consultants-Clarkston
  • Newland Medical Associates-Clarkston
  • Beaumont Hospital - Dearborn
  • Green Bay Oncology - Escanaba
  • Beaumont Hospital - Farmington Hills
  • Genesee Cancer and Blood Disease Treatment Center
  • Genesee Hematology Oncology PC
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Mercy Health Saint Mary's
  • Spectrum Health at Butterworth Campus
  • William Beaumont Hospital-Grosse Pointe
  • Saint Mary Mercy Hospital
  • Mercy Health Mercy Campus
  • Newland Medical Associates-Pontiac
  • Saint Joseph Mercy Oakland
  • Spectrum Health Reed City Hospital
  • William Beaumont Hospital-Royal Oak
  • Ascension Saint Mary's Hospital
  • Oncology Hematology Associates of Saginaw Valley PC
  • Ascension Saint Joseph Hospital
  • Munson Medical Center
  • William Beaumont Hospital - Troy
  • Saint Mary's Oncology/Hematology Associates of West Branch
  • Metro Health Hospital
  • IHA Hematology Oncology Consultants-Ann Arbor
  • Fairview Ridges Hospital
  • Mercy Hospital
  • Fairview Southdale Hospital
  • Unity Hospital
  • Fairview Clinics and Surgery Center Maple Grove
  • Minnesota Oncology Hematology PA-Maplewood
  • Saint John's Hospital - Healtheast
  • Abbott-Northwestern Hospital
  • Hennepin County Medical Center
  • Health Partners Inc
  • New Ulm Medical Center
  • North Memorial Medical Health Center
  • Park Nicollet Clinic - Saint Louis Park
  • Regions Hospital
  • United Hospital
  • Saint Francis Regional Medical Center
  • Lakeview Hospital
  • Ridgeview Medical Center
  • Rice Memorial Hospital
  • Minnesota Oncology Hematology PA-Woodbury
  • Fairview Lakes Medical Center
  • Baptist Memorial Hospital and Cancer Center-Golden Triangle
  • Baptist Memorial Hospital and Cancer Center-Union County
  • Baptist Memorial Hospital and Cancer Center-Oxford
  • Baptist Memorial Hospital and Cancer Center-Desoto
  • Capital Region Southwest Campus
  • Missouri Baptist Medical Center
  • Mercy Hospital Springfield
  • CHI Health Good Samaritan
  • Randolph Hospital
  • Mission Hospital
  • AdventHealth Infusion Center Asheville
  • Hope Women's Cancer Centers-Asheville
  • Gaston Hematology and Oncology Associates-Belmont
  • UNC Lineberger Comprehensive Cancer Center
  • Wake Forest University at Clemmons
  • Southeastern Medical Oncology Center-Clinton
  • CaroMont Regional Medical Center
  • Gaston Hematology and Oncology Associates
  • Southeastern Medical Oncology Center-Goldsboro
  • Cone Health Cancer Center
  • Margaret R Pardee Memorial Hospital
  • AdventHealth Hendersonville
  • Southeastern Medical Oncology Center-Jacksonville
  • Wake Forest University Health Sciences
  • Sanford Bismarck Medical Center
  • Sanford Broadway Medical Center
  • Sanford Roger Maris Cancer Center
  • Strecker Cancer Center-Belpre
  • Good Samaritan Hospital - Cincinnati
  • Bethesda North Hospital
  • TriHealth Cancer Institute-Westside
  • TriHealth Cancer Institute-Anderson
  • Columbus Oncology and Hematology Associates Inc
  • Riverside Methodist Hospital
  • Armes Family Cancer Center
  • Marietta Memorial Hospital
  • Licking Memorial Hospital
  • Kaiser Permanente Northwest
  • Geisinger Medical Center
  • Geisinger Medical Center-Cancer Center Hazleton
  • Geisinger Medical Oncology-Lewisburg
  • Geisinger Cancer Services-Pottsville
  • Community Medical Center
  • Geisinger Medical Oncology-Selinsgrove
  • Geisinger Wyoming Valley/Henry Cancer Center
  • AnMed Health Cancer Center
  • Prisma Health Cancer Institute - Spartanburg
  • Prisma Health Cancer Institute - Easley
  • Gibbs Cancer Center-Gaffney
  • Tidelands Georgetown Memorial Hospital
  • Prisma Health Cancer Institute - Butternut
  • Prisma Health Cancer Institute - Faris
  • Prisma Health Cancer Institute - Eastside
  • Self Regional Healthcare
  • Prisma Health Cancer Institute - Greer
  • Gibbs Cancer Center-Pelham
  • Prisma Health Cancer Institute - Seneca
  • Spartanburg Medical Center
  • MGC Hematology Oncology-Union
  • Sanford Cancer Center Oncology Clinic
  • Sanford USD Medical Center - Sioux Falls
  • Baptist Memorial Hospital and Cancer Center-Memphis
  • Baptist Memorial Hospital for Women
  • Family Cancer Center-Memphis
  • Meharry Medical College
  • Aurora Cancer Care-Southern Lakes VLCC
  • Marshfield Clinic-Chippewa Center
  • Marshfield Medical Center-EC Cancer Center
  • Aurora Health Center-Fond du Lac
  • Aurora Health Care Germantown Health Center
  • Aurora Cancer Care-Grafton
  • Saint Vincent Hospital Cancer Center Green Bay
  • Saint Vincent Hospital Cancer Center at Saint Mary's
  • Aurora BayCare Medical Center
  • Aurora Cancer Care-Kenosha South
  • Gundersen Lutheran Medical Center
  • Marshfield Clinic - Ladysmith Center
  • Holy Family Memorial Hospital
  • Aurora Bay Area Medical Group-Marinette
  • Saint Vincent Hospital Cancer Center at Marinette
  • Marshfield Medical Center-Marshfield
  • Aurora Cancer Care-Milwaukee
  • Aurora Saint Luke's Medical Center
  • Aurora Sinai Medical Center
  • Marshfield Clinic-Minocqua Center
  • Cancer Center of Western Wisconsin
  • Saint Vincent Hospital Cancer Center at Oconto Falls
  • Vince Lombardi Cancer Clinic - Oshkosh
  • Aurora Cancer Care-Racine
  • Marshfield Medical Center-Rice Lake
  • Vince Lombardi Cancer Clinic-Sheboygan
  • Marshfield Clinic Stevens Point Center
  • Saint Vincent Hospital Cancer Center at Sturgeon Bay
  • Aurora Medical Center in Summit
  • Vince Lombardi Cancer Clinic-Two Rivers
  • Marshfield Clinic-Wausau Center
  • Aurora Cancer Care-Milwaukee West
  • Aurora West Allis Medical Center
  • Marshfield Medical Center - Weston
  • Marshfield Clinic - Wisconsin Rapids Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Donepezil

Placebo

Arm Description

Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5 mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Outcomes

Primary Outcome Measures

Hopkins Verbal Learning Test-Revised (HVLT-R) - Total
Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to patients on three successive learning trials. Free recall scores are recorded for each learning trial. After a 20-minute interval during which patients complete other non-interfering tasks and questionnaires they are asked to recall the target words. Range is 0-36 with higher values representing better verbal learning and memory.

Secondary Outcome Measures

Digit Symbol Coding Results
The digit symbol coding (DSC) test measures processing speed, working memory, visuospatial processing, and attention. The DSC test measures processing speed. It requires respondents to transcribe symbols (e.g., >) associated with a number (0-9) into empty boxes beneath a series of randomly ordered numbers. Total score is number of correctly transcribed symbols in 2 minutes. Scores range from 0 to 100, with higher scores indicating higher cognitive function.
PROMIS 7-item Fatigue Scale Converted to T-scale Results
This self-report scale assesses fatigue. Scale ranges from 7 to 35 converted to T-scale ranging 29.4 to 83.2 Higher scores representing more fatigue.
FACT-Cognition (Version 3): Perceived Cognitive Impairment
The FACT-Cog is a patient-reported outcome (PRO) that includes subscales to measure Perceived Cognitive Impairment (PCI, n = 20 items, score range 0-80). Higher FACT-Cog PCI scores are better and indicate less cognitive impairment.
Controlled Oral Word Association Test (COWA) Results
The Controlled Oral Word Association Test from the Halstead-Reitan Neuropsychological Battery is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Scores are the sum of all acceptable words. Minimum is 0 with no specified maximum; higher values represent better verbal fluency.
Trail Making Test, Parts A & B (TMT-A, TMT-B) Results
TMT Part A consists of 25 circles on a piece of paper with the numbers 1 to 25 written randomly in each. For Part A, the person is tasked with drawing a line from one circle to the next in ascending numerical order, from 1 to 25, as quickly as possible. The lines between the circles are referred to as the "trail." Range 1-300 in seconds. Lower values indicate completing task faster with less difficulty. It is a measure of executive functioning with lower values being better. TMT Part B also consists of 25 circles on a piece of paper, But, rather than all of the circles containing numbers, they contain numbers (1 to 12) and letters (A through L). For Part B, the person is tasked with connecting the circles in ascending order, alternating back and forth from numbers to letters. In other words, the "trail" would be connected like this:1-A-2-B-3-C-4-D-5-E-6-F-7-G-8-H-9-I-10-J-11-K-12-L-13. The range 1-300 seconds. Higher values indicate worse executive functioning.
Digit Span Test-Backwards (DST-B)
The Digit Span Task (Backwards-Only Version) measures working memory. On each question the participant repeats the numbers in reverse order of that presented aloud by the examiner (e.g., If the examiner says "5-6", the correct response would be "6-5"; If the examiner says "5-1-7-4-2-3-8", the correct response would be "8-3-2-4-7-1-5"). Score is 0 to 16 with higher scores representing better working memory.

Full Information

First Posted
June 30, 2016
Last Updated
August 17, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02822573
Brief Title
Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil
Acronym
Remember
Official Title
A Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors With Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to compare the safety and effects of donepezil (Aricept) for patients reporting cognitive or memory issues after receiving chemotherapy for breast cancer. Patients will receive either donepezil or placebo for 24 weeks. The primary objective is to see if memory improves with the use of donepezil during the study.
Detailed Description
Randomized, double-blind, placebo-controlled study with 24 weeks of exposure to drug or placebo followed by a 12 week wash-out period. Patients who meet the eligibility criteria will be stratified by age (<50, 50-59, 60-69, ≥70) and randomized to donepezil or placebo with equal probability. A total of 276 patients will be enrolled (138 per arm). We expect an accrual rate of 7-10 participants per month based on our prior feasibility study. We expect the study to be complete within 40 months. Participants will be asked to take one 5mg tablet of donepezil or one tablet of matching placebo orally once a day for 6 weeks followed by two 5mg tablets (10mg total) of donepezil or two placebo tablets orally once a day for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period. Time points for performing study assessments. Participants will be administered the cognitive battery of tests and questionnaires at baseline, week 12, week 24 and week 36. In addition, a single vial of blood will be drawn at baseline for apolipoprotein E (APOE) genotyping and subsequent bioassays (pending supplemental funding).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction, Memory Impairment
Keywords
Donepezil, Cognition, Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Donepezil
Arm Type
Active Comparator
Arm Description
Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5 mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
Intervention Type
Drug
Intervention Name(s)
Donepezil 5 mg
Other Intervention Name(s)
Aricept
Intervention Description
Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
Primary Outcome Measure Information:
Title
Hopkins Verbal Learning Test-Revised (HVLT-R) - Total
Description
Hopkins Verbal Learning Test-Revised (HVLT-R): The HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to patients on three successive learning trials. Free recall scores are recorded for each learning trial. After a 20-minute interval during which patients complete other non-interfering tasks and questionnaires they are asked to recall the target words. Range is 0-36 with higher values representing better verbal learning and memory.
Time Frame
Baseline, Weeks 12, 24, 36
Secondary Outcome Measure Information:
Title
Digit Symbol Coding Results
Description
The digit symbol coding (DSC) test measures processing speed, working memory, visuospatial processing, and attention. The DSC test measures processing speed. It requires respondents to transcribe symbols (e.g., >) associated with a number (0-9) into empty boxes beneath a series of randomly ordered numbers. Total score is number of correctly transcribed symbols in 2 minutes. Scores range from 0 to 100, with higher scores indicating higher cognitive function.
Time Frame
Baseline, Weeks 12, 24, 36
Title
PROMIS 7-item Fatigue Scale Converted to T-scale Results
Description
This self-report scale assesses fatigue. Scale ranges from 7 to 35 converted to T-scale ranging 29.4 to 83.2 Higher scores representing more fatigue.
Time Frame
Baseline, Weeks 12, 24, 36
Title
FACT-Cognition (Version 3): Perceived Cognitive Impairment
Description
The FACT-Cog is a patient-reported outcome (PRO) that includes subscales to measure Perceived Cognitive Impairment (PCI, n = 20 items, score range 0-80). Higher FACT-Cog PCI scores are better and indicate less cognitive impairment.
Time Frame
Baseline, Weeks 12, 24, 36
Title
Controlled Oral Word Association Test (COWA) Results
Description
The Controlled Oral Word Association Test from the Halstead-Reitan Neuropsychological Battery is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Scores are the sum of all acceptable words. Minimum is 0 with no specified maximum; higher values represent better verbal fluency.
Time Frame
Baseline, Weeks 12, 24, 36
Title
Trail Making Test, Parts A & B (TMT-A, TMT-B) Results
Description
TMT Part A consists of 25 circles on a piece of paper with the numbers 1 to 25 written randomly in each. For Part A, the person is tasked with drawing a line from one circle to the next in ascending numerical order, from 1 to 25, as quickly as possible. The lines between the circles are referred to as the "trail." Range 1-300 in seconds. Lower values indicate completing task faster with less difficulty. It is a measure of executive functioning with lower values being better. TMT Part B also consists of 25 circles on a piece of paper, But, rather than all of the circles containing numbers, they contain numbers (1 to 12) and letters (A through L). For Part B, the person is tasked with connecting the circles in ascending order, alternating back and forth from numbers to letters. In other words, the "trail" would be connected like this:1-A-2-B-3-C-4-D-5-E-6-F-7-G-8-H-9-I-10-J-11-K-12-L-13. The range 1-300 seconds. Higher values indicate worse executive functioning.
Time Frame
Baseline, Weeks 12, 24, 36
Title
Digit Span Test-Backwards (DST-B)
Description
The Digit Span Task (Backwards-Only Version) measures working memory. On each question the participant repeats the numbers in reverse order of that presented aloud by the examiner (e.g., If the examiner says "5-6", the correct response would be "6-5"; If the examiner says "5-1-7-4-2-3-8", the correct response would be "8-3-2-4-7-1-5"). Score is 0 to 16 with higher scores representing better working memory.
Time Frame
Baseline, Weeks 12, 24, 36

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women ≥18 years old with history of invasive breast cancer Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to registration (Ongoing herceptin or other chronic human epidermal growth factor receptor 2 (HER2) directed therapies are allowed). Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and plan to continue for the duration of the study (9 months) Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks. Patients who were previously on one of these psychotropic medications and have subsequently discontinued the drug must have been off the medication for at least 4 weeks prior to enrollment. Patients who have been on a psychotropic medication for at least 12 weeks but have recently switched to a medicine in the same class (for example, switching from one selective serotonin reuptake inhibitor (SSRI) antidepressant to a different SSRI antidepressant) need to be on a stable dose of the new medication for at least 4 weeks prior to enrollment to be eligible. Self-reported cognitive problem plus a measured memory deficit (score <7 on single trial of Eligibility Pre-screen Hopkins Verbal Learning Test - Revised (HVLT-R) Form 3). Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Ability to understand and the willingness to sign a written informed consent document. Must be able to speak English. Patients currently taking a moderate risk corrected QT interval (QTc) prolongation medication (see Appendix A) are allowed if one of the following criteria are met: 1) The moderate risk QTc prolongation medication is stopped. The patient should be off the moderate risk QTc prolongation medication for at least 5 half-lives before starting study drug. 2) Patients that continue using a moderate risk QTc prolongation medication must have a normal QTc interval (≤ 460 milliseconds) on a screening ECG following informed consent and prior to study enrollment. These patients will also be monitored at designated study follow-up visits per Section 7.5 (monitored 3-7 days after initiating study drug, at week 3, and 3-7 days after the study drug dose increase with ECG's to assess the QTc interval; the QTc level must be ≤ 500 milliseconds at these time points in order to continue on the study drug). 3) Moderate risk QTc prolongation medications that are only taken occasionally may be stopped at the discretion of the treating site physician. Patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible. Patients currently taking a moderate risk bradycardia-causing agent (see Appendix B) are allowed if one of the following criteria are met: 1) The moderate risk bradycardia-causing agent is stopped. The patient should be off the moderate risk bradycardia-causing agent for at least 5 half-lives before starting study drug. 2) Patients that continue using a moderate risk bradycardia-causing agent must have a resting heart rate ≥ 55 beats per minute at screening following informed consent. These patients' resting heart rate will be monitored 3-7 days after initiating study drug, at week 3, and 3-7 days after the study drug dose increase per Section 7.5. 3) Moderate risk bradycardia-causing agents that are only taken occasionally may be stopped at the discretion of the treating site physician. Patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible. Exclusion Criteria: Evidence or suspected recurrent or metastatic disease. Prior brain irradiation is not allowed. Planned therapy (surgery, radiation, chemotherapy, or immunotherapy) while on the study for brain and/or extracranial primary/metastatic disease. Hypersensitivity to donepezil or piperidine derivatives Current use of ceritinib Current use of Succinylcholine/Acetylcholinesterase Inhibitors(as listed in Appendix C). For patients who have used these medications, they must not have used them within 4 weeks prior to enrollment. Current use of high-risk QTc prolonging medication(s). See Appendix D Current use of quinidine or systemic ketoconazole (topical ketoconazole is acceptable to use while on study). History of dementia, Alzheimer's disease, multi-infarct dementia or clinically significant Cerebrovascular Accident (history of transient ischemic attack (TIA) is allowed). Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drug(s). For patients who have used these medications, they must not have used them within 4 weeks prior to pre-screening. Patients who plan to start taking a cognition enhancing drug while on this study are also excluded. History of allergic reactions attributed to compounds of similar chemical or biologic composition to donepezil. Hypersensitivity to donepezil. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia. Major medical conditions that affect cognition, traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia. Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse. Untreated current severe depression. Currently treated depression is permitted if treatment is stable. Patients with a resting heart rate less than 55 beats per minute, seizure disorder or peptic ulcer disease (PUD). History of congenital long QT syndrome or torsades de pointes. Screening QTc of > 460 milliseconds will make the patient ineligible. Pregnant women are excluded from this study. Following informed consent, women of child-bearing potential will be screened with a serum or urine pregnancy test within 10 days of enrollment. The effects of donepezil on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because donepezil is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breast-feeding are not eligible for this study. On another intervention study involving medication at the time of enrollment or during participation in this study. (Exception: Patients will remain eligible for this study if they are also enrolled on the Alliance for Clinical Trials in Oncology study (NCT02927249): Aspirin in Preventing Recurrence of Cancer in Patients with HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy. Studies that involve only blood draws or questionnaires are also permitted.) Use of investigational drugs likely to affect cognition within 30 days prior to pre-screening visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen R Rapp, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente-Anaheim
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
Kaiser Permanente-Deer Valley Medical Center
City
Antioch
State/Province
California
ZIP/Postal Code
94531
Country
United States
Facility Name
Kaiser Permanente-Baldwin Park
City
Baldwin Park
State/Province
California
ZIP/Postal Code
91706
Country
United States
Facility Name
Kaiser Permanente-Bellflower
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Kaiser Permanente-Fontana
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Facility Name
Kaiser Permanente-Fremont
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Fresno Cancer Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Kaiser Permanente-Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Kaiser Permanente - Harbor City
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
Kaiser Permanente-Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Permanente West Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90034
Country
United States
Facility Name
Kaiser Permanente-Modesto
City
Modesto
State/Province
California
ZIP/Postal Code
95356
Country
United States
Facility Name
Kaiser Permanente-Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente-Ontario
City
Ontario
State/Province
California
ZIP/Postal Code
91761
Country
United States
Facility Name
Kaiser Permanente - Panorama City
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Kaiser Permanente-Rancho Cordova Cancer Center
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Kaiser Permanente-Richmond
City
Richmond
State/Province
California
ZIP/Postal Code
94801
Country
United States
Facility Name
Kaiser Permanente-Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Kaiser Permanente-Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
The Permanente Medical Group-Roseville Radiation Oncology
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Facility Name
Kaiser Permanente Downtown Commons
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Facility Name
Kaiser Permanente-South Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
South Sacramento Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Kaiser Permanente-San Diego Zion
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Kaiser Permanente-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente-Santa Teresa-San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente San Leandro
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Facility Name
Kaiser Permanente-San Marcos
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Kaiser Permanente-San Rafael
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Kaiser San Rafael-Gallinas
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Kaiser Permanente-Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Kaiser Permanente-South San Francisco
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Kaiser Permanente-Stockton
City
Stockton
State/Province
California
ZIP/Postal Code
95210
Country
United States
Facility Name
Kaiser Permanente Medical Center-Vacaville
City
Vacaville
State/Province
California
ZIP/Postal Code
95688
Country
United States
Facility Name
Kaiser Permanente-Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Kaiser Permanente-Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Kaiser Permanente-Woodland Hills
City
Woodland Hills
State/Province
California
ZIP/Postal Code
91367
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Penrose
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Kaiser Permanente-Franklin
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Kaiser Permanente-Rock Creek
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Littleton Adventist Hospital
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80122
Country
United States
Facility Name
Kaiser Permanente-Lone Tree
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Parker Adventist Hospital
City
Parker
State/Province
Colorado
ZIP/Postal Code
80138
Country
United States
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Medical Oncology Hematology Consultants PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Facility Name
TidalHealth Nanticoke / Allen Cancer Center
City
Seaford
State/Province
Delaware
ZIP/Postal Code
19973
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Pali Momi Medical Center
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Hawaii Cancer Care Inc - Waterfront Plaza
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Cancer Cenrer - POB I
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Straub Clinic and Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Hawaii Cancer Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Hawaii Cancer Care Inc-Liliha
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Queen's Cancer Center - Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kaiser Permanente Moanalua Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Saint Luke's Cancer Institute - Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Illinois CancerCare-Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Illinois CancerCare-Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Centralia Oncology Clinic
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
Carle on Vermilion
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
Cancer Care Specialists of Illinois - Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Carle Physician Group-Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Illinois CancerCare-Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare-Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Illinois CancerCare-Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Illinois CancerCare-Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
The Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Physicians' Clinic of Iowa PC
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52402
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Broadlawns Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
Methodist West Hospital
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266-7700
Country
United States
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Cancer Center of Kansas-Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Cancer Center of Kansas-Manhattan
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66502
Country
United States
Facility Name
Cancer Center of Kansas - McPherson
City
McPherson
State/Province
Kansas
ZIP/Postal Code
67460
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cancer Center of Kansas - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates In Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Ascension Via Christi Hospitals Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Flaget Memorial Hospital
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Saint Joseph Radiation Oncology Resource Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Saint Joseph Hospital East
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Saint Joseph London
City
London
State/Province
Kentucky
ZIP/Postal Code
40741
Country
United States
Facility Name
Christus Saint Frances Cabrini Hospital
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
LSU Health Baton Rouge-North Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70805
Country
United States
Facility Name
Louisiana Hematology Oncology Associates LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Our Lady of the Lake Physicians Group - Medical Oncology
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Louisiana State University Health Science Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CHRISTUS Highland Medical Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
IHA Hematology Oncology Consultants-Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Facility Name
Saint Joseph Mercy Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Facility Name
IHA Hematology Oncology Consultants-Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Facility Name
Saint Joseph Mercy Canton
City
Canton
State/Province
Michigan
ZIP/Postal Code
48188
Country
United States
Facility Name
Caro Cancer Center
City
Caro
State/Province
Michigan
ZIP/Postal Code
48723
Country
United States
Facility Name
IHA Hematology Oncology Consultants-Chelsea
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Name
Saint Joseph Mercy Chelsea
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
Country
United States
Facility Name
Hematology Oncology Consultants-Clarkston
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Newland Medical Associates-Clarkston
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
Beaumont Hospital - Dearborn
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Green Bay Oncology - Escanaba
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49829
Country
United States
Facility Name
Beaumont Hospital - Farmington Hills
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Genesee Cancer and Blood Disease Treatment Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Genesee Hematology Oncology PC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Mercy Health Saint Mary's
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
William Beaumont Hospital-Grosse Pointe
City
Grosse Pointe
State/Province
Michigan
ZIP/Postal Code
48230
Country
United States
Facility Name
Saint Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Mercy Health Mercy Campus
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Newland Medical Associates-Pontiac
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Spectrum Health Reed City Hospital
City
Reed City
State/Province
Michigan
ZIP/Postal Code
49677
Country
United States
Facility Name
William Beaumont Hospital-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Ascension Saint Mary's Hospital
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Oncology Hematology Associates of Saginaw Valley PC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Ascension Saint Joseph Hospital
City
Tawas City
State/Province
Michigan
ZIP/Postal Code
48764
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
William Beaumont Hospital - Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Saint Mary's Oncology/Hematology Associates of West Branch
City
West Branch
State/Province
Michigan
ZIP/Postal Code
48661
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
IHA Hematology Oncology Consultants-Ann Arbor
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Fairview Clinics and Surgery Center Maple Grove
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Maplewood
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Health Partners Inc
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
New Ulm Medical Center
City
New Ulm
State/Province
Minnesota
ZIP/Postal Code
56073
Country
United States
Facility Name
North Memorial Medical Health Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Saint Francis Regional Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Lakeview Hospital
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Fairview Lakes Medical Center
City
Wyoming
State/Province
Minnesota
ZIP/Postal Code
55092
Country
United States
Facility Name
Baptist Memorial Hospital and Cancer Center-Golden Triangle
City
Columbus
State/Province
Mississippi
ZIP/Postal Code
39705
Country
United States
Facility Name
Baptist Memorial Hospital and Cancer Center-Union County
City
New Albany
State/Province
Mississippi
ZIP/Postal Code
38652
Country
United States
Facility Name
Baptist Memorial Hospital and Cancer Center-Oxford
City
Oxford
State/Province
Mississippi
ZIP/Postal Code
38655
Country
United States
Facility Name
Baptist Memorial Hospital and Cancer Center-Desoto
City
Southhaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Capital Region Southwest Campus
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Missouri Baptist Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CHI Health Good Samaritan
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68847
Country
United States
Facility Name
Randolph Hospital
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
AdventHealth Infusion Center Asheville
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Hope Women's Cancer Centers-Asheville
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28816
Country
United States
Facility Name
Gaston Hematology and Oncology Associates-Belmont
City
Belmont
State/Province
North Carolina
ZIP/Postal Code
28012
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Forest University at Clemmons
City
Clemmons
State/Province
North Carolina
ZIP/Postal Code
27012
Country
United States
Facility Name
Southeastern Medical Oncology Center-Clinton
City
Clinton
State/Province
North Carolina
ZIP/Postal Code
28328
Country
United States
Facility Name
CaroMont Regional Medical Center
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Gaston Hematology and Oncology Associates
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Southeastern Medical Oncology Center-Goldsboro
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Cone Health Cancer Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Margaret R Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
AdventHealth Hendersonville
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28792
Country
United States
Facility Name
Southeastern Medical Oncology Center-Jacksonville
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Sanford Bismarck Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Strecker Cancer Center-Belpre
City
Belpre
State/Province
Ohio
ZIP/Postal Code
45714
Country
United States
Facility Name
Good Samaritan Hospital - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
TriHealth Cancer Institute-Westside
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45247
Country
United States
Facility Name
TriHealth Cancer Institute-Anderson
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Columbus Oncology and Hematology Associates Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Armes Family Cancer Center
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Kaiser Permanente Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Geisinger Medical Center-Cancer Center Hazleton
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Geisinger Medical Oncology-Lewisburg
City
Lewisburg
State/Province
Pennsylvania
ZIP/Postal Code
17837
Country
United States
Facility Name
Geisinger Cancer Services-Pottsville
City
Pottsville
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States
Facility Name
Community Medical Center
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
Facility Name
Geisinger Medical Oncology-Selinsgrove
City
Selinsgrove
State/Province
Pennsylvania
ZIP/Postal Code
17870
Country
United States
Facility Name
Geisinger Wyoming Valley/Henry Cancer Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Prisma Health Cancer Institute - Spartanburg
City
Boiling Springs
State/Province
South Carolina
ZIP/Postal Code
29316
Country
United States
Facility Name
Prisma Health Cancer Institute - Easley
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Gibbs Cancer Center-Gaffney
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29341
Country
United States
Facility Name
Tidelands Georgetown Memorial Hospital
City
Georgetown
State/Province
South Carolina
ZIP/Postal Code
29440
Country
United States
Facility Name
Prisma Health Cancer Institute - Butternut
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Cancer Institute - Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Cancer Institute - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Self Regional Healthcare
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Facility Name
Prisma Health Cancer Institute - Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Gibbs Cancer Center-Pelham
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Prisma Health Cancer Institute - Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
MGC Hematology Oncology-Union
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
Baptist Memorial Hospital and Cancer Center-Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Baptist Memorial Hospital for Women
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Family Cancer Center-Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Aurora Cancer Care-Southern Lakes VLCC
City
Burlington
State/Province
Wisconsin
ZIP/Postal Code
53105
Country
United States
Facility Name
Marshfield Clinic-Chippewa Center
City
Chippewa Falls
State/Province
Wisconsin
ZIP/Postal Code
54729
Country
United States
Facility Name
Marshfield Medical Center-EC Cancer Center
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
Aurora Health Center-Fond du Lac
City
Fond Du Lac
State/Province
Wisconsin
ZIP/Postal Code
54937
Country
United States
Facility Name
Aurora Health Care Germantown Health Center
City
Germantown
State/Province
Wisconsin
ZIP/Postal Code
53022
Country
United States
Facility Name
Aurora Cancer Care-Grafton
City
Grafton
State/Province
Wisconsin
ZIP/Postal Code
53024
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center at Saint Mary's
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Facility Name
Aurora Cancer Care-Kenosha South
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Marshfield Clinic - Ladysmith Center
City
Ladysmith
State/Province
Wisconsin
ZIP/Postal Code
54848
Country
United States
Facility Name
Holy Family Memorial Hospital
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54221
Country
United States
Facility Name
Aurora Bay Area Medical Group-Marinette
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center at Marinette
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Aurora Cancer Care-Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Aurora Sinai Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Facility Name
Cancer Center of Western Wisconsin
City
New Richmond
State/Province
Wisconsin
ZIP/Postal Code
54017
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center at Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
Vince Lombardi Cancer Clinic - Oshkosh
City
Oshkosh
State/Province
Wisconsin
ZIP/Postal Code
54904
Country
United States
Facility Name
Aurora Cancer Care-Racine
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53406
Country
United States
Facility Name
Marshfield Medical Center-Rice Lake
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
Vince Lombardi Cancer Clinic-Sheboygan
City
Sheboygan
State/Province
Wisconsin
ZIP/Postal Code
53081
Country
United States
Facility Name
Marshfield Clinic Stevens Point Center
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54482
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center at Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235-1495
Country
United States
Facility Name
Aurora Medical Center in Summit
City
Summit
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Name
Vince Lombardi Cancer Clinic-Two Rivers
City
Two Rivers
State/Province
Wisconsin
ZIP/Postal Code
54241
Country
United States
Facility Name
Marshfield Clinic-Wausau Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Aurora Cancer Care-Milwaukee West
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Aurora West Allis Medical Center
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Marshfield Medical Center - Weston
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Marshfield Clinic - Wisconsin Rapids Center
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base is committed to following the NIH Statement on Sharing Research Data. As of July 2018, the Wake Forest (WF) NCORP Research Base (RB) signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI National Clinical Trials Network (NCTN)/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide.
IPD Sharing Time Frame
See NIH Policy
IPD Sharing Access Criteria
request using link below
IPD Sharing URL
https://nctn-data-archive.nci.nih.gov/

Learn more about this trial

Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil

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