Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction
Condition: Anxiety Disorder; Breast Cancer; Cognition Disorders; Depression; Fatigue; Sleep Disorders
MeSH terms: Breast Neoplasms; Sleep Wake Disorders; Parasomnias; Fatigue; Depression; Anxiety Disorders; Cognitive Dysfunction; Cognition Disorders
Intervention: donepezil hydrochloride; Placebo
Intervention description: Given PO; Given PO
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: fatigue; sleep disorders; depression; anxiety disorder; cognitive/functional effects; breast cancer; cancer survivor

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.
    

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.