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)
- 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
- Determine the natural history of cognitive decline in these patients after cancer
- 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
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 104 patients (52 per arm) will be accrued for this study
within 3 years.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Aminah Jatoi, MD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Scottsdale Oncology Program||Scottsdale, Arizona 85259-5404|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Siouxland Hematology-Oncology||Sioux City, Iowa 51101-1733|
|CCOP - Merit Care Hospital||Fargo, North Dakota 58122|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|Allegheny General Hospital||Pittsburgh, Pennsylvania 15212-4772|
|Mayo Clinic||Jacksonville, Florida 32224|
|Medcenter One Health System||Bismarck, North Dakota 58501|