Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: alpha-Tocopherol; Donepezil; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of small cell lung cancer (SCLC)

• Must meet one of the following conditions:

• Enrolled no more than 4 weeks before initiation of prophylactic cranial irradiation (PCI) OR

• Enrolled no more than 10 days after initiation of PCI

• Limited or extensive stage SCLC with complete response (CR) outside chest allowed

• Must have CR or minimal disease after completion of intended course of chemotherapy

• No disease progression since initiation of PCI

• No prior or concurrent CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

Renal:

• Creatinine no greater than 2 times upper limit of normal

Cardiovascular:

• No sick sinus syndrome or other symptomatic supraventricular conduction disorders even if symptoms currently controlled by antiarrhythmics

Pulmonary:

• No history of asthma or chronic obstructive pulmonary disease requiring chronic oxygen therapy

Other:

• No medical or psychiatric condition that would increase risk

• No seizure disorder

• No ongoing alcohol abuse

PRIOR CONCURRENT THERAPY:

Chemotherapy:

• See Disease Characteristics

• No concurrent anticancer chemotherapy

Other:

• No concurrent medications that would impair baseline cognitive function or are likely to be dose escalated over the next few months

• No other concurrent vitamin E