Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain
- Compare the effect of donepezil hydrochloride vs placebo, in terms of improving
neurocognitive symptom cluster (i.e., cognitive impairment, subjective confusion, and
fatigue), in patients who have undergone partial- or whole-brain irradiation for brain
- Compare the effect of these regimens on mood and quality of life in these patients.
OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized, multicenter
study. Patients are stratified according to prior brain irradiation type (whole-brain vs
partial-brain) and study site. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral donepezil hydrochloride once or twice daily for up to 24
weeks in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo once or twice daily for up to 24 weeks in the
absence of unacceptable toxicity.
Patients complete self-reported questionnaires (quality of life, fatigue, subjective
confusion, neurocognitive battery, and mood) at baseline and 12 and 24 weeks.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Fatigue, subjective confusion, and cognitive performance at 24 weeks
Stephen Rapp, PhD
Wake Forest University
United States: Federal Government
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - MeritCare Hospital||Fargo, North Dakota 58122|
|MetroHealth Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44109|
|Thompson Cancer Survival Center||Knoxville, Tennessee 37916|
|Via Christi Cancer Center at Via Christi Regional Medical Center||Wichita, Kansas 67214|
|Don Monti Comprehensive Cancer Center at North Shore University Hospital||Manhasset, New York 11030|
|Gundersen Lutheran Center for Cancer and Blood||La Crosse, Wisconsin 54601|
|Cancer Center of Kansas, PA - Wichita||Wichita, Kansas 67214|
|Associates in Womens Health, PA - North Review||Wichita, Kansas 67208|
|Cancer Center of Kansas, PA - Medical Arts Tower||Wichita, Kansas 67208|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|Lakes Region General Hospital||Laconia, New Hampshire 03246|
|New Hampshire Oncology - Hematology, PA - Hooksett||Hooksett, New Hampshire 03106|
|Trinity CancerCare Center||Minot, North Dakota 58701|
|United States Air Force Medical Center - Wright-Patterson||Wright-Patterson AFB, Ohio 45433-5529|
|Central Maine Comprehensive Cancer Center at Central Maine Medical Center||Lewiston, Maine 04240|