Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01466270|
Recruitment Status : Completed
First Posted : November 7, 2011
Results First Posted : January 9, 2015
Last Update Posted : August 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorder Breast Cancer Cognition Disorders Depression Fatigue Sleep Disorders||Drug: donepezil hydrochloride Drug: Placebo||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Feasibility Study of Donepezil in Female Breast Cancer Survivors With Self-Reported Cognitive Dysfunction Following Chemotherapy|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Arm I
Patients receive donepezil hydrochloride PO QD.
Drug: donepezil hydrochloride
Other Name: Donepezil
Placebo Comparator: Arm II
Patients receive placebo PO QD.
- Retention [ Time Frame: 24 Weeks ]Retention is the percentage of participants who stay in the study for 24 weeks.
- Compliance [ Time Frame: 24 weeks ]Compliance is the percentage of pills taken while on study (based on returned diaries)
- HVLT-IR [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466270
|Principal Investigator:||Julia A. Lawrence||Wake Forest University Health Sciences|