Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer
NCT00006349 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2016-07-13
Summary
RATIONALE: Donepezil and vitamin E may be able to decrease side effects caused by radiation therapy given to prevent brain metastases in patients with small cell lung cancer. It is not yet known if donepezil and vitamin E are effective in preventing side effects caused by radiation therapy to the head.
PURPOSE: Randomized phase III trial to determine the effectiveness of donepezil and vitamin E in preventing side effects caused by radiation therapy given to prevent brain metastases in patients who have small cell lung cancer.
Conditions
- Cognitive/Functional Effects
- Delirium
- Depression
- Lung Cancer
- Radiation Toxicity
Interventions
- DIETARY_SUPPLEMENT
-
vitamin E
- DRUG
-
donepezil hydrochloride
- OTHER
-
placebo
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Alliance for Clinical Trials in Oncology
lead OTHER
Principal Investigators
-
Aminah Jatoi, MD · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-02-28
- Primary Completion
- 2005-01-31
- Completion
- 2007-01-31
Countries
- United States
Study Locations
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