Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors

Phase 3

Completed

• Conditions: Brain Tumors; Metastatic Disease
• Interventions: Drug: Placebo; Drug: donepezil hydrochloride

• Registration Number: NCT00369785
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors. It is not yet known whether donepezil is more effective than a placebo in lessening side effects of radiation therapy in patients with brain tumors.

PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2006-08-24
• Study First Submitted QC: 2006-08-24
• Study First Posted: 2006-08-29
• Study Start: 2008-02
• Primary Completion: 2012-07-01
• Study Completion: 2012-07-01
• Results First Submitted: 2015-07-15
• Results First Submitted QC: 2017-01-18
• Results First Posted: 2017-03-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II - Control	Placebo	Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day
Arm I - Donepezil	donepezil hydrochloride	Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day

Primary Outcome Measures

Name	Time	Method
Memory as Quantified by the HVLT-discrimination	24 weeks	In the Hopkins Verbal Learning Test - discrimination, participants are given lists of 12 correct words and 12 incorrect words. HVLT-discrimination is the number of correctly recognized words minus the number incorrectly recognized. The range for this outcome measure is -12 to 12. Higher scores represent better memory.
Memory as Quantified by HVLT-immediate Recall	24 weeks	Memory is quantified using the Hopkins Verbal Learning Test (HVLT) - immediate recall. Participants are asked to recall 12 words. Each recalled word is given one point. They are given three trials. The total score is the sum of the recalled words. The range for HVLT-Immediate recall is 0 to 36. Higher scores represent better memory.

Trial Locations

Locations (16)

Gundersen Lutheran Center for Cancer and Blood; 🇺🇸 La Crosse, Wisconsin, United States

United States Air Force Medical Center - Wright-Patterson; 🇺🇸 Wright-Patterson Air Force Base, Ohio, United States

Cancer Center of Kansas, PA - Wichita; 🇺🇸 Wichita, Kansas, United States

Associates in Womens Health, PA - North Review; 🇺🇸 Wichita, Kansas, United States

Central Maine Comprehensive Cancer Center at Central Maine Medical Center; 🇺🇸 Lewiston, Maine, United States

Cancer Center of Kansas, PA - Medical Arts Tower; 🇺🇸 Wichita, Kansas, United States

New Hampshire Oncology - Hematology, PA - Hooksett; 🇺🇸 Hooksett, New Hampshire, United States

Don Monti Comprehensive Cancer Center at North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

Summa Center for Cancer Care at Akron City Hospital; 🇺🇸 Akron, Ohio, United States

Trinity CancerCare Center; 🇺🇸 Minot, North Dakota, United States

CCOP - MeritCare Hospital; 🇺🇸 Fargo, North Dakota, United States

MetroHealth Cancer Care Center at MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Lakes Region General Hospital; 🇺🇸 Laconia, New Hampshire, United States

Thompson Cancer Survival Center; 🇺🇸 Knoxville, Tennessee, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center; 🇺🇸 Wichita, Kansas, United States