Conditions: Anxiety Disorder Breast Cancer Cognition Disorders Depression Fatigue Sleep Disorders
Keywords: fatigue sleep disorders depression anxiety disorder cognitive/functional effects breast cancer cancer survivor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 62
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Patients receive donepezil hydrochloride PO QD. arm 2: Patients receive placebo PO QD.

Interventions: intervention 1: donepezil hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol document: