Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction
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.
Drug: donepezil hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Feasibility Study of Donepezil in Female Breast Cancer Survivors With Self-Reported Cognitive Dysfunction Following Chemotherapy|
- Retention [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]Retention is the percentage of participants who stay in the study for 24 weeks.
- Compliance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Compliance is the percentage of pills taken while on study (based on returned diaries)
- HVLT-IR [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive donepezil hydrochloride PO QD.
Drug: donepezil hydrochloride
Other Name: Donepezil
Placebo Comparator: Arm II
Patients receive placebo PO QD.
Other Name: Placebo
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466270
|United States, North Carolina|
|Wake Forest Cancer Center CCOP Research Base|
|Winston Salem, North Carolina, United States, 27157|
|Principal Investigator:||Julia A. Lawrence||Comprehensive Cancer Center of Wake Forest University|