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Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer

Primary Purpose

Hot Flashes, Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
gabapentin
placebo
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hot Flashes focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer, hot flashes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Required characteristics: Men with a history of prostate cancer who have received or are receiving androgen ablation therapy. Must be on a stable dose of hormone therapy for the past 4 weeks and must not be planning on discontinuing hormone therapy throughout the duration of the randomized phase (5 weeks). Presence of hot flashes for ≥1 month prior to study entry. Bothersome hot flashes (defined by their occurrence ≥14 times per week and of sufficient severity to make the patient desire therapeutic intervention). Life expectancy ≥ 6 months. ECOG Performance Status (PS) 0 or 1. ≥18 years of age Contraindications: History of renal insufficiency (defined as a creatinine ≥1.5 x UNL in the last two years). Any of the following current (≤ 4 weeks) or planned therapies: Antineoplastic chemotherapy Androgens Estrogens Progestational agents History of allergic or other adverse reaction to gabapentin. Prior use of gabapentin. Antidepressants (use is allowed if patient has been on a stable dose for ≥1 month and does not plan to modify this treatment during the next 5 weeks).

Sites / Locations

  • Mobile Infirmary Medical Center
  • Howard University Cancer Center at Howard University Hospital
  • Mayo Clinic - Jacksonville
  • Kapiolani Medical Center at Pali Momi
  • Leeward Radiation Oncology Center
  • Cancer Research Center of Hawaii
  • OnCare Hawaii, Incorporated - Lusitana
  • Queen's Cancer Institute at Queen's Medical Center
  • Straub Clinic and Hospital, Incorporated
  • OnCare Hawaii, Incorporated - Kuakini
  • St. Francis Medical Center
  • Kapiolani Medical Center for Women and Children
  • Rush-Copley Cancer Care Center
  • St. Joseph Medical Center
  • Graham Hospital
  • Memorial Hospital
  • St. Anthony's Memorial Hospital
  • Eureka Community Hospital
  • Galesburg Clinic
  • Galesburg Cottage Hospital
  • Mason District Hospital
  • Hopedale Medical Complex
  • Joliet Oncology-Hematology Associates, Limited - West
  • Kewanee Hospital
  • McDonough District Hospital
  • Trinity Medical Center - East
  • BroMenn Regional Medical Center
  • Community Cancer Center
  • Community Hospital of Ottawa
  • Oncology Hematology Associates of Central Illinois, PC - Ottawa
  • Cancer Treatment Center at Pekin Hospital
  • Proctor Hospital
  • CCOP - Illinois Oncology Research Association
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
  • Methodist Medical Center of Illinois
  • OSF St. Francis Medical Center
  • Illinois Valley Community Hospital
  • Perry Memorial Hospital
  • St. Margaret's Hospital
  • Carle Cancer Center at Carle Foundation Hospital
  • CCOP - Carle Cancer Center
  • Saint Anthony Memorial Health Centers
  • McFarland Clinic, PC
  • St. Luke's Hospital
  • Cedar Rapids Oncology Associates
  • Mercy Regional Cancer Center at Mercy Medical Center
  • Mercy Capitol Hospital
  • CCOP - Iowa Oncology Research Association
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  • Medical Oncology and Hematology Associates at Mercy Cancer Center
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
  • John Stoddard Cancer Center at Iowa Lutheran Hospital
  • Mercy Cancer Center at Mercy Medical Center - North Iowa
  • Ottumwa Regional Health Center Cancer Center
  • Siouxland Hematology-Oncology Associates, LLP
  • Siouxland Regional Cancer Center
  • Mercy Medical Center - Sioux City
  • St. Luke's Regional Medical Center
  • Medical Oncology and Hematology Associates - West Des Moines
  • Cancer Center of Kansas, PA - Chanute
  • Cancer Center of Kansas, PA - Dodge City
  • Cancer Center of Kansas, PA - El Dorado
  • Cancer Center of Kansas, PA - Kingman
  • Southwest Medical Center
  • Cancer Center of Kansas, PA - Newton
  • Cancer Center of Kansas, PA - Parsons
  • Cancer Center of Kansas, PA - Pratt
  • Cancer Center of Kansas, PA - Salina
  • Cancer Center of Kansas, PA - Wellington
  • Associates in Womens Health, PA - North Review
  • Cancer Center of Kansas, PA - Medical Arts Tower
  • Cancer Center of Kansas, PA - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Cancer Center of Kansas, PA - Winfield
  • Hickman Cancer Center at Bixby Medical Center
  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
  • CCOP - Michigan Cancer Research Consortium
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Foote Hospital
  • Haematology-Oncology Associates of Ohio and Michigan, PC
  • Sparrow Regional Cancer Center
  • Community Cancer Center of Monroe
  • Mercy Memorial Hospital System
  • Seton Cancer Institute - Saginaw
  • St. John Macomb Hospital
  • Albert Lea Cancer Center at Albert Lea Medical Center
  • Brainerd Medical Center
  • St. Joseph's Medical Center
  • CCOP - Duluth
  • Miller-Dwan Medical Center
  • St. Mary's - Duluth Clinic Cancer Center
  • Chippewa County - Montevideo Hospital
  • Mayo Clinic Cancer Center
  • Coborn Cancer Center
  • Adult and Pediatric Urology, P.L.L.P.
  • CentraCare Clinic - River Campus
  • Willmar Cancer Center at Rice Memorial Hospital
  • CCOP - Montana Cancer Consortium
  • Hematology-Oncology Centers of the Northern Rockies - Billings
  • Northern Rockies Radiation Oncology Center
  • St. Vincent Healthcare
  • Deaconess Billings Clinic - Downtown
  • Bozeman Deaconess Hospital
  • St. James Community Hospital
  • Great Falls Clinic
  • St. Peter's Hospital
  • Glacier Oncology, PLLC
  • Kalispell Medical Oncology
  • Kalispell Regional Medical Center
  • Community Medical Center
  • Clinic of Dr. Judy L. Schmidt
  • Montana Cancer Specialists at Montana Cancer Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • Cancer Resource Center - Lincoln
  • CCOP - Missouri Valley Cancer Consortium
  • Immanuel Medical Center
  • Alegant Health Cancer Center at Bergan Mercy Medical Center
  • Creighton University Medical Center
  • Rutherford Hospital
  • Bismarck Cancer Center
  • Cancer Care Center at Medcenter One Hospital
  • Mid Dakota Clinic, P. C.
  • St. Alexius Medical Center
  • Wood County Oncology Center
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Riverside Cancer Services
  • Mount Carmel Health - West Hospital
  • Doctors Hospital at Ohio Health
  • Grady Memorial Hospital
  • Blanchard Valley Medical Associates
  • Fremont Memorial Hospital
  • Kenton Oncology, Incorporated
  • Fairfield Medical Center
  • Lima Memorial Hospital
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Northwest Ohio Oncology Center
  • St. Luke's Hospital
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • St. Charles Mercy Hospital
  • Toledo Clinic - Oregon
  • Firelands Regional Medical Center
  • North Coast Cancer Care, Incorporated
  • Mercy Medical Center
  • Community Hospital of Springfield and Clark County
  • Flower Hospital Cancer Center
  • Mercy Hospital of Tiffin
  • Toledo Hospital
  • St. Vincent Mercy Medical Center
  • Medical University of Ohio Cancer Center
  • CCOP - Toledo Community Hospital
  • Toledo Clinic, Incorporated - Main Clinic
  • Fulton County Health Center
  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
  • Genesis - Good Samaritan Hospital
  • Allegheny Cancer Center at Allegheny General Hospital
  • AnMed Health Cancer Center
  • CCOP - Upstate Carolina
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  • Rapid City Regional Hospital
  • Welch Cancer Center at Sheridan Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Gabapentin (28 days)

Gabapentin (7, 21)

Gabapentin (7, 7, 14)

Placebo

Arm Description

Oral Gabapentin 300 mg days 1-28

Oral Gabapentin 300 mg once daily on days 1-7 days and twice daily days 8-28

Oral Gabapentin 300 mg once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28

Oral Placebo 300 mg on one of the following schedules: once daily on days 1-28 once daily on days 1-7, twice daily on days 8-28 once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28

Outcomes

Primary Outcome Measures

Hot flash reduction by diary scores at 4 weeks

Secondary Outcome Measures

Toxicity by questionnaires at 4 weeks

Full Information

First Posted
January 4, 2002
Last Updated
June 27, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00028574
Brief Title
Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
Official Title
A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Gabapentin may be effective in relieving hot flashes in men who have prostate cancer. It is not yet known which regimen of gabapentin is most effective in treating hot flashes. PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating men who have prostate cancer.
Detailed Description
OBJECTIVES: Determine the effectiveness of gabapentin in managing hot flashes in men with prostate cancer. Determine the response of patients to this drug. Determine the toxicity of this drug in these patients. Determine the quality of life of patients treated with this drug. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to the number of hot flashes per day (2-3 vs 4-9 vs 10 or more) and duration of hot flash symptoms (less than 9 months vs 9 months or more). Patients are randomized to one of four treatment arms. All patients are observed for 7 days prior to drug administration in order to collect baseline hot flash information. Arm I: Patients receive oral gabapentin once daily on days 1-28. Arm II: Patients receive oral gabapentin once daily on days 1-7 and twice daily on days 8-28. Arm III: Patients receive oral gabapentin once daily on days 1-7, twice daily on days 8-14, and three times daily on days 15-28. Arm IV: Patients receive oral placebo on one of three schedules corresponding to arms I-III. Patients in all arms may continue therapy with gabapentin for an additional 8 weeks. Quality of life is assessed at baseline, day 28, and at the end of the additional 8 weeks. Patients are followed at 6, 12, and 24 months. PROJECTED ACCRUAL: A total of 220 patients (55 per treatment arm) will be accrued for this study within 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Prostate Cancer
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer, hot flashes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
223 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin (28 days)
Arm Type
Active Comparator
Arm Description
Oral Gabapentin 300 mg days 1-28
Arm Title
Gabapentin (7, 21)
Arm Type
Active Comparator
Arm Description
Oral Gabapentin 300 mg once daily on days 1-7 days and twice daily days 8-28
Arm Title
Gabapentin (7, 7, 14)
Arm Type
Active Comparator
Arm Description
Oral Gabapentin 300 mg once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo 300 mg on one of the following schedules: once daily on days 1-28 once daily on days 1-7, twice daily on days 8-28 once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28
Intervention Type
Drug
Intervention Name(s)
gabapentin
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Hot flash reduction by diary scores at 4 weeks
Time Frame
5 weeks from study entry
Secondary Outcome Measure Information:
Title
Toxicity by questionnaires at 4 weeks
Time Frame
5 weeks from study entry

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Required characteristics: Men with a history of prostate cancer who have received or are receiving androgen ablation therapy. Must be on a stable dose of hormone therapy for the past 4 weeks and must not be planning on discontinuing hormone therapy throughout the duration of the randomized phase (5 weeks). Presence of hot flashes for ≥1 month prior to study entry. Bothersome hot flashes (defined by their occurrence ≥14 times per week and of sufficient severity to make the patient desire therapeutic intervention). Life expectancy ≥ 6 months. ECOG Performance Status (PS) 0 or 1. ≥18 years of age Contraindications: History of renal insufficiency (defined as a creatinine ≥1.5 x UNL in the last two years). Any of the following current (≤ 4 weeks) or planned therapies: Antineoplastic chemotherapy Androgens Estrogens Progestational agents History of allergic or other adverse reaction to gabapentin. Prior use of gabapentin. Antidepressants (use is allowed if patient has been on a stable dose for ≥1 month and does not plan to modify this treatment during the next 5 weeks).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Loprinzi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36652-2144
Country
United States
Facility Name
Howard University Cancer Center at Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Kapiolani Medical Center at Pali Momi
City
Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Leeward Radiation Oncology Center
City
Ewa Beach
State/Province
Hawaii
ZIP/Postal Code
96706
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolula
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
OnCare Hawaii, Incorporated - Lusitana
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Cancer Institute at Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Straub Clinic and Hospital, Incorporated
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
OnCare Hawaii, Incorporated - Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
St. Francis Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
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
Rush-Copley Cancer Care Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60507
Country
United States
Facility Name
St. Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Graham Hospital
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
St. Anthony's Memorial Hospital
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Eureka Community Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Galesburg Clinic
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Galesburg Cottage Hospital
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Mason District Hospital
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Hopedale Medical Complex
City
Hopedale
State/Province
Illinois
ZIP/Postal Code
61747
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Limited - West
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Kewanee Hospital
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
McDonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Trinity Medical Center - East
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
BroMenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Hospital of Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Cancer Treatment Center at Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois Valley Community Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
St. Margaret's Hospital
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Carle Cancer Center at Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Saint Anthony Memorial Health Centers
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
McFarland Clinic, PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
St. Luke's Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52402
Country
United States
Facility Name
Cedar Rapids Oncology Associates
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Mercy Capitol Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50307
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at Mercy Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316-2301
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - North Iowa
City
Mason City
State/Province
Iowa
ZIP/Postal Code
50401
Country
United States
Facility Name
Ottumwa Regional Health Center Cancer Center
City
Ottumwa
State/Province
Iowa
ZIP/Postal Code
52501
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Siouxland Regional Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Medical Oncology and Hematology Associates - West Des Moines
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Cancer Center of Kansas, PA - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas, PA - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas, PA - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas, PA - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Southwest Medical Center
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas, PA - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cancer Center of Kansas, PA - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas, PA - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas, PA - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health, PA - North Review
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Cancer Center of Kansas, PA - Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas, PA - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Hickman Cancer Center at Bixby Medical Center
City
Adrian
State/Province
Michigan
ZIP/Postal Code
49221
Country
United States
Facility Name
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123-2500
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
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Foote Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Haematology-Oncology Associates of Ohio and Michigan, PC
City
Lambertville
State/Province
Michigan
ZIP/Postal Code
48144
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48909
Country
United States
Facility Name
Community Cancer Center of Monroe
City
Monroe
State/Province
Michigan
ZIP/Postal Code
48162
Country
United States
Facility Name
Mercy Memorial Hospital System
City
Monroe
State/Province
Michigan
ZIP/Postal Code
48162
Country
United States
Facility Name
Seton Cancer Institute - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Albert Lea Cancer Center at Albert Lea Medical Center
City
Albert Lea
State/Province
Minnesota
ZIP/Postal Code
56007
Country
United States
City
Alexandria
State/Province
Minnesota
ZIP/Postal Code
56308
Country
United States
Facility Name
Brainerd Medical Center
City
Brainerd
State/Province
Minnesota
ZIP/Postal Code
56401
Country
United States
Facility Name
St. Joseph's Medical Center
City
Brainerd
State/Province
Minnesota
ZIP/Postal Code
56401
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Miller-Dwan Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
St. Mary's - Duluth Clinic Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
City
Fergus Falls
State/Province
Minnesota
ZIP/Postal Code
56537
Country
United States
Facility Name
Chippewa County - Montevideo Hospital
City
Montevideo
State/Province
Minnesota
ZIP/Postal Code
56265
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Coborn Cancer Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Adult and Pediatric Urology, P.L.L.P.
City
Sartell
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
CentraCare Clinic - River Campus
City
St. Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Willmar Cancer Center at Rice Memorial Hospital
City
Willmar
State/Province
Minnesota
ZIP/Postal Code
56201
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Deaconess Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
St. James Community Hospital
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology, PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Clinic of Dr. Judy L. Schmidt
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807
Country
United States
Facility Name
Cancer Resource Center - Lincoln
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Immanuel Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68122
Country
United States
Facility Name
Alegant Health Cancer Center at Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-2197
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139
Country
United States
Facility Name
Bismarck Cancer Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Cancer Care Center at Medcenter One Hospital
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Mid Dakota Clinic, P. C.
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
St. Alexius Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58502
Country
United States
Facility Name
Wood County Oncology Center
City
Bowling Green
State/Province
Ohio
ZIP/Postal Code
43402
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Riverside Cancer Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel Health - West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Blanchard Valley Medical Associates
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Fremont Memorial Hospital
City
Fremont
State/Province
Ohio
ZIP/Postal Code
43420
Country
United States
Facility Name
Kenton Oncology, Incorporated
City
Kenton
State/Province
Ohio
ZIP/Postal Code
43326
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
Lima Memorial Hospital
City
Lima
State/Province
Ohio
ZIP/Postal Code
45804
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Northwest Ohio Oncology Center
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
St. Luke's Hospital
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
St. Charles Mercy Hospital
City
Oregon
State/Province
Ohio
ZIP/Postal Code
43616
Country
United States
Facility Name
Toledo Clinic - Oregon
City
Oregon
State/Province
Ohio
ZIP/Postal Code
43616
Country
United States
Facility Name
Firelands Regional Medical Center
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
North Coast Cancer Care, Incorporated
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Mercy Medical Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Flower Hospital Cancer Center
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Mercy Hospital of Tiffin
City
Tiffin
State/Province
Ohio
ZIP/Postal Code
44883
Country
United States
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
St. Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Medical University of Ohio Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
CCOP - Toledo Community Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Toledo Clinic, Incorporated - Main Clinic
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Fulton County Health Center
City
Wauseon
State/Province
Ohio
ZIP/Postal Code
43567
Country
United States
Facility Name
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Genesis - Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Allegheny Cancer Center at Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Welch Cancer Center at Sheridan Memorial Hospital
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19129205
Citation
Loprinzi CL, Dueck AC, Khoyratty BS, Barton DL, Jafar S, Rowland KM Jr, Atherton PJ, Marsa GW, Knutson WH, Bearden JD 3rd, Kottschade L, Fitch TR. A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB). Ann Oncol. 2009 Mar;20(3):542-9. doi: 10.1093/annonc/mdn644. Epub 2009 Jan 6.
Results Reference
result
PubMed Identifier
20552926
Citation
Moraska AR, Atherton PJ, Szydlo DW, Barton DL, Stella PJ, Rowland KM Jr, Schaefer PL, Krook J, Bearden JD, Loprinzi CL. Gabapentin for the management of hot flashes in prostate cancer survivors: a longitudinal continuation Study-NCCTG Trial N00CB. J Support Oncol. 2010 May-Jun;8(3):128-32.
Results Reference
result

Learn more about this trial

Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer

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