NCT01466270

Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction

A Feasibility Study of Donepezil in Female Breast Cancer Survivors With Self-Reported Cognitive Dysfunction Following Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Anxiety Disorder
• Breast Cancer
• Cognition Disorders
• Depression
• Fatigue
• Sleep Disorders

Interventions

Type	Name	Description
DRUG	donepezil hydrochloride	Given PO
DRUG	Placebo	Given PO

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2011-11-07
• Last updated: 2021-10-20
• Results posted: 2015-01-09

Regulatory

• FDA-regulated drug study