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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Donepezil and Vitamin E in the Prevention of Cognitive Dysfunction Following Cancer Treatment That Included Prophylactic Cranial Irradiation in Patients With Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	NCCTG-N99C5 NCI-P00-0169, NCT00006349

Trial Description

Purpose:

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.

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.

Eligibility:

• At least 18 years old
• No more than 4 weeks since beginning radiation therapy to the head
• No CNS metastases
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Within 2 weeks after completing radiation therapy to the head, patients will be randomly assigned to one of two groups. Patients in group one will receive donepezil by mouth once a day and vitamin E by mouth twice a day. Patients in group two will receive placebos by mouth as in group one. Treatment may continue for at least 1 month. Quality of life will be assessed periodically. Patients will be evaluated every 3-6 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-284-4918

Registry Information
Official Title		An Exploratory Trial of Donepezil and Vitamin E to Prevent Cognitive Dysfunction in Patients with Small Cell Lung Cancer (SCLC) After Cancer Treatment Which Includes Prophylatic Cranial Irradiation (PCI)
Trial Start Date		2001-02-06
Registered in ClinicalTrials.gov		NCT00006349
Date Submitted to PDQ		2000-08-04
Information Last Verified		2002-12-03
NCI Grant/Contract Number		CA31946

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