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Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
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.
OBJECTIVES: Primary * 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. Secondary * 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)
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Regional Radiation Oncology Center at Rome
Rome, Georgia, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Start Date
July 1, 2001
Primary Completion Date
May 1, 2005
Completion Date
August 1, 2012
Last Updated
September 9, 2021
68
ACTUAL participants
EGb761
DIETARY_SUPPLEMENT
donepezil hydrochloride
DRUG
cognitive assessment
PROCEDURE
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT05530655
NCT04940936
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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