A Feasibility Study of Donepezil in Female Breast Cancer Survivors With Self-Reported Cognitive Dysfunction Following Chemotherapy
- Determine the feasibility of conducting a randomized placebo-controlled clinical trial
for cognitive symptoms in female breast cancer survivors.
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Julia A. Lawrence
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest Cancer Center CCOP Research Base||Winston Salem, North Carolina 27157|