Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
RATIONALE: Donepezil and EGb761 may be effective in improving neurocognitive function (such as thinking, attention, concentration, and memory) and may improve quality of life in patients who have undergone radiation therapy to the brain.
PURPOSE: This phase II trial is studying how well donepezil or EGb761 works in improving neurocognitive function in patients who have undergone radiation therapy for primary brain tumor or brain metastases.
|Brain and Central Nervous System Tumors Radiation Toxicity||Dietary Supplement: EGb761 Drug: donepezil hydrochloride Procedure: cognitive assessment||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Supportive Care
|Official Title:||Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases|
|Study Start Date:||July 2001|
|Study Completion Date:||August 2012|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
- Determine the effect of donepezil or EGb761 on neurocognitive function in patients who underwent radiotherapy for a primary brain tumor or brain metastases at least 6 months before study registration.
- Determine the toxicity of these drugs in these patients.
- Determine the quality of life of patients treated with these drugs.
- Quantify the extent of radiation-induced white matter disease and temporal lobe atrophy in patients treated with these drugs.
OUTLINE: This is an open-label, multicenter study.
- Group 1 (closed to accrual 10/09/03): Patients receive oral donepezil once daily for 24 weeks.
- Group 2: Patients receive oral EGb761 three times daily for 24 weeks. In both groups (group 1 closed to accrual 10/09/03), treatment continues in the absence of unacceptable toxicity.
In both groups (group 1 closed to accrual 10/09/03), quality of life and neurocognitive assessment is performed at baseline and at weeks 6 (group 1 only), 12, 24, and 30.
Patients are followed at 6 weeks.
PROJECTED ACCRUAL: A total of 70 patients (35 per treatment group) will be accrued for this study within 9.5 months. (Group 1 closed to accrual 10/09/03)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070161
|United States, Arizona|
|CCOP - Western Regional, Arizona|
|Phoenix, Arizona, United States, 85006-2726|
|United States, Georgia|
|Regional Radiation Oncology Center at Rome|
|Rome, Georgia, United States, 30165|
|United States, North Carolina|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1030|
|United States, South Carolina|
|CCOP - Upstate Carolina|
|Spartanburg, South Carolina, United States, 29303|
|Study Chair:||Edward G. Shaw, MD||Wake Forest University Health Sciences|