Quality of life and cognitive dysfunction in breast cancer survivors on a feasibility study of donepezil versus placebo.

9516 Background: Breast cancer survivors report long term cognitive and quality of life effects due to cancer and chemotherapy. Cognitive enhancers (donepezil) could be a treatment option. We conducted a randomized, placebo-controlled phase II study to determine the feasibility of a larger phase III trial to improve cognitive function in breast cancer survivors with self-reported cognitive problems 1 to 5 years following chemotherapy. Methods: 62 patients were randomized to receive donepezil (5mg x 6 weeks + 10 mg x 18 weeks) or placebo. Participants completed a comprehensive battery of neurocognitive tests and questionnaires measuring cognitive symptoms, mood, fatigue, sleep disturbance and quality of life at baseline, 24, and 36 weeks post randomization. Women were screened for cognitive impairment with the FACT-Cog Perceived Cognitive Impairment subscale and were eligible if they scored <63. Results: The study opened at 16 sites and enrolled 62 women over 6 months (accrual rate of 10.2subjects/month). ...