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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Given PO
Given PO
Retention
Retention is the percentage of participants who stay in the study for 24 weeks.
Time frame: 24 Weeks
Compliance
Compliance is the percentage of pills taken while on study (based on returned diaries)
Time frame: 24 weeks
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.
Time frame: 24 weeks
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.
Time frame: 24 weeks
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Masking
QUADRUPLE
Enrollment
62