Breast Cancer Clinical Trial
Official title:
A Feasibility Study of Donepezil in Female Breast Cancer Survivors With Self-Reported Cognitive Dysfunction Following Chemotherapy
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. ;
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