Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain
OBJECTIVES:
Primary
- 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
tumors.
Secondary
- 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.
Interventional
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
24 weeks
No
Stephen Rapp, PhD
Principal Investigator
Wake Forest University
United States: Federal Government
CCCWFU91105
NCT00369785
January 2008
June 2012
Name | Location |
---|---|
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 |