Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction
- Conditions
- Anxiety DisorderDepressionCognition DisordersFatigueBreast CancerSleep Disorders
- Interventions
- Drug: Placebo
- Registration Number
- NCT01466270
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 62
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II Placebo Patients receive placebo PO QD. Arm I donepezil hydrochloride Patients receive donepezil hydrochloride PO QD.
- Primary Outcome Measures
Name Time Method Retention 24 Weeks Retention is the percentage of participants who stay in the study for 24 weeks.
Compliance 24 weeks Compliance is the percentage of pills taken while on study (based on returned diaries)
- Secondary Outcome Measures
Name Time Method HVLT-IR 24 weeks Hopkins verbal learning test - immediate recall is the number of words (of 12) than can be remembers during three tries. The total score ranges from 0 to 36. Higher is better.
Fatigue 24 weeks Fatigue is quantified by the FACIT-Fatigue scale. It consists of 13 questions answered on a 0 to 4 point scale. The fatigue score is the sum of the responses (some reverse scored) so that higher values represent less fatigue.