Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors
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.
Timeline
- Start
- 2008-02
- Primary completion
- 2012-07-01
- Completion
- 2012-07-01
Outcome
Mixed primary results
registry analysis (unspecified test); Arm I - Donepezil vs Arm II - Control; p = .62; Mixed Models Analysis NCT00369785 ↗
registry LEAST_SQUARES_MEAN Arm I - Donepezil: 10.1 (Standard Error 0.24) units on a scale NCT00369785 ↗
registry LEAST_SQUARES_MEAN Arm II - Control: 9.2 (Standard Error 0.24) units on a scale NCT00369785 ↗
registry analysis (unspecified test); Arm I - Donepezil vs Arm II - Control; p = .007; Mixed Models Analysis NCT00369785 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Donepezil | Small molecule | 10 mg | Oral |