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Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction

Primary Purpose

Anxiety Disorder, Breast Cancer, Cognition Disorders

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
donepezil hydrochloride
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 Anxiety Disorder focused on measuring fatigue, sleep disorders, depression, anxiety disorder, cognitive/functional effects, breast cancer, cancer survivor

Eligibility Criteria

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

INCLUSION CRITERIA:

  • Adults >18 years old.
  • Female with history of invasive breast cancer
  • Must have completed adjuvant chemotherapy between 1 and 5 years prior to registration
  • Received at least 4 cycles of cytotoxic chemotherapy
  • Documentation of prior chemotherapy
  • 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 continue for the duration of the study (9 months)
  • Karnofsky Performance Status must be > 60 or ECOG 0-2.
  • 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.
  • Patients must be able to give informed consent to participate in the study, including signing the consent form.
  • Self-reported cognitive disruption (FACT-Cog Version 3 Perceived Cognitive Impairments sub-score of < 63)
  • Negative serum pregnancy test within 10 days prior to registration for women of child-bearing potential.

EXCLUSION CRITERIA:

  • Evidence or suspected recurrent or metastatic disease
  • History of dementia, Alzheimer's disease, multi-infarct dementia or CVA (history of transient ischemic attack (TIA is allowed)
  • Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drugs.are not allowed. For patients who have used these medications they must not have used them within 4 weeks prior to registration.

Patients may not currently be taking Ketoconazole or Quinidine

  • Hypersensitivity to donepezil.
  • Use of investigational medications within the last 30 days.
  • Prior brain metastasis
  • Traumatic brain injury, multiple sclerosis or recent myocardial infarction
  • History of schizophrenia, psychosis or substance abuse
  • Untreated current severe depression. (Currently treated depression is permitted if treatment is stable.)
  • Acute severe fatigue, chronic fatigue syndrome or fibromyalgia.
  • History of hepatic or renal dysfunction or disease
  • Pregnant women are excluded from this study. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Arm I

    Arm II

    Arm Description

    Patients receive donepezil hydrochloride PO QD.

    Patients receive placebo PO QD.

    Outcomes

    Primary Outcome Measures

    Retention
    Retention is the percentage of participants who stay in the study for 24 weeks.
    Compliance
    Compliance is the percentage of pills taken while on study (based on returned diaries)

    Secondary Outcome Measures

    HVLT-IR
    Hopkins verbal learning test - immediate recall is the number of words (of 12) than can be remembers during three tries. The total score ranges from 0 to 36. Higher is better.
    Fatigue
    Fatigue is quantified by the FACIT-Fatigue scale. It consists of 13 questions answered on a 0 to 4 point scale. The fatigue score is the sum of the responses (some reverse scored) so that higher values represent less fatigue.

    Full Information

    First Posted
    November 2, 2011
    Last Updated
    September 27, 2021
    Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01466270
    Brief Title
    Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction
    Official Title
    A Feasibility Study of Donepezil in Female Breast Cancer Survivors With Self-Reported Cognitive Dysfunction Following Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (Actual)
    Primary Completion Date
    October 1, 2013 (Actual)
    Study Completion Date
    October 1, 2013 (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
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Donepezil hydrochloride may help lessen cognitive dysfunction caused by chemotherapy. PURPOSE: This phase II trial is studying donepezil hydrochloride in treating cognitive dysfunction after chemotherapy in female breast cancer survivors.
    Detailed Description
    OBJECTIVES: Primary Determine the feasibility of conducting a randomized placebo-controlled clinical trial for cognitive symptoms in female breast cancer survivors. Secondary Estimate the variability of the clinical outcomes (FACT-Cognition Perceived Cognitive Impairment subscale, neurocognitive battery, FACIT-Fatigue, FACT Cog Total Score, PROMIS Fatigue, Epworth Sleepiness Scale, Beck Depression Inventory, Beck Anxiety Inventory, and RAND Short Form-36). Estimate the within patient correlation over time of the clinical outcomes. Obtain preliminary estimates of the effect of donepezil on the primary and secondary outcome variables. Correlate the reports of fatigue, sleep disturbance, and mood with measures of cognitive symptoms and neurocognitive test performance. Document the severity of cognitive symptoms and functional impairment in female breast cancer survivors who enroll on this pilot study. Correlate cognitive symptoms with cognitive test performance. Document the toxicities associated with donepezil hydrochloride use. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to menopausal status (pre- vs peri-/post-menopausal) and time since end of chemotherapy (12-36 months vs 36.01-60 months). Arm I: Patients receive donepezil hydrochloride orally (PO) once daily (QD). Arm II: Patients receive placebo PO QD. In both arms treatment continues for 24 weeks. Patients complete the entire battery of neurocognitive tests and questionnaires (FACT-Cognition Perceived Cognitive Impairment subscale, neurocognitive battery, FACIT-Fatigue, FACT Cog Total Score, PROMIS Fatigue, Epworth Sleepiness Scale, Beck Depression Inventory, Beck Anxiety Inventory, and RAND Short Form-36) at baseline (pre-treatment), 24 weeks (end of medication), and 36 weeks (end of wash-out). After completion of therapy, patients are followed at 12 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorder, Breast Cancer, Cognition Disorders, Depression, Fatigue, Sleep Disorders
    Keywords
    fatigue, sleep disorders, depression, anxiety disorder, cognitive/functional effects, breast cancer, cancer survivor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I
    Arm Type
    Experimental
    Arm Description
    Patients receive donepezil hydrochloride PO QD.
    Arm Title
    Arm II
    Arm Type
    Placebo Comparator
    Arm Description
    Patients receive placebo PO QD.
    Intervention Type
    Drug
    Intervention Name(s)
    donepezil hydrochloride
    Other Intervention Name(s)
    Donepezil
    Intervention Description
    Given PO
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Given PO
    Primary Outcome Measure Information:
    Title
    Retention
    Description
    Retention is the percentage of participants who stay in the study for 24 weeks.
    Time Frame
    24 Weeks
    Title
    Compliance
    Description
    Compliance is the percentage of pills taken while on study (based on returned diaries)
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    HVLT-IR
    Description
    Hopkins verbal learning test - immediate recall is the number of words (of 12) than can be remembers during three tries. The total score ranges from 0 to 36. Higher is better.
    Time Frame
    24 weeks
    Title
    Fatigue
    Description
    Fatigue is quantified by the FACIT-Fatigue scale. It consists of 13 questions answered on a 0 to 4 point scale. The fatigue score is the sum of the responses (some reverse scored) so that higher values represent less fatigue.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    INCLUSION CRITERIA: Adults >18 years old. Female with history of invasive breast cancer Must have completed adjuvant chemotherapy between 1 and 5 years prior to registration Received at least 4 cycles of cytotoxic chemotherapy Documentation of prior chemotherapy 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 continue for the duration of the study (9 months) Karnofsky Performance Status must be > 60 or ECOG 0-2. 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. Patients must be able to give informed consent to participate in the study, including signing the consent form. Self-reported cognitive disruption (FACT-Cog Version 3 Perceived Cognitive Impairments sub-score of < 63) Negative serum pregnancy test within 10 days prior to registration for women of child-bearing potential. EXCLUSION CRITERIA: Evidence or suspected recurrent or metastatic disease History of dementia, Alzheimer's disease, multi-infarct dementia or CVA (history of transient ischemic attack (TIA is allowed) Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drugs.are not allowed. For patients who have used these medications they must not have used them within 4 weeks prior to registration. Patients may not currently be taking Ketoconazole or Quinidine Hypersensitivity to donepezil. Use of investigational medications within the last 30 days. Prior brain metastasis Traumatic brain injury, multiple sclerosis or recent myocardial infarction History of schizophrenia, psychosis or substance abuse Untreated current severe depression. (Currently treated depression is permitted if treatment is stable.) Acute severe fatigue, chronic fatigue syndrome or fibromyalgia. History of hepatic or renal dysfunction or disease Pregnant women are excluded from this study. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julia A. Lawrence
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction

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