Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor

Phase 2

Completed

• Conditions: Radiation Toxicity; Brain and Central Nervous System Tumors

• Registration Number: NCT00070161
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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)

Study Timeline

• Study Start: 2001-07-01
• Study First Submitted: 2003-10-03
• Study First Submitted QC: 2003-10-06
• Study First Posted: 2003-10-07
• Primary Completion: 2005-05-01
• Study Completion: 2012-08-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (4)

Comprehensive Cancer Center at Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Regional Radiation Oncology Center at Rome; 🇺🇸 Rome, Georgia, United States

CCOP - Upstate Carolina; 🇺🇸 Spartanburg, South Carolina, United States

CCOP - Western Regional, Arizona; 🇺🇸 Phoenix, Arizona, United States