NCT00006349

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: * Compare the interval between completion of cancer treatment that included prophylactic cranial irradiation and onset of cognitive decline in patients with small cell lung cancer (SCLC) treated with donepezil and vitamin E vs placebo. * Determine the toxicity of donepezil and vitamin E in these patients. * Determine whether preserved cognitive function favorably impacts quality of life in these patients. * Determine the natural history of cognitive decline in these patients after cancer treatment. * Determine whether genotypes of apolipoprotein E predict decline in cognitive function among patients at risk for treatment-associated dementia and whether these genotypes predict duration of disease-free survival among patients who have achieved complete response after treatment for SCLC. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to cognitive function (normal vs mild to moderate dysfunction vs severe dysfunction) and age (60 and under vs over 60). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral donepezil daily and vitamin E twice daily. * Arm II: Patients receive oral placebos according to the same schedule as the study drugs in arm I. All patients begin treatment within 2 weeks after completion of prophylactic cranial irradiation. Treatment continues for a minimum of 1 month in the absence of disease progression, unacceptable toxicity, or a 3.0 point drop on the Mini Mental State Examination (MMSE) and/or a 5 point drop on the Blessed Dementia Scale. Cognition is assessed using the Blessed Dementia Scale and the MMSE at baseline and then every 3 months during study. Quality of life and depression are assessed at baseline and then every 3 months during study. Patients are followed every 6 months.

Conditions

• Cognitive/Functional Effects
• Delirium
• Depression
• Lung Cancer
• Radiation Toxicity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin E
DRUG	donepezil hydrochloride
OTHER	placebo

Timeline

• Start date: 2001-02-01
• Primary completion: 2005-01-01
• Completion: 2007-01-01
• First posted: 2003-05-29
• Last updated: 2016-07-13

Locations

15 sites across 1 country: United States