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)
Sponsor study identifier
Secondary identifiers
REGISTRY · PDQ (Physician Data Query)
interventional
9
1 country
15
Study Start
February 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2005
Actual (reported)Study Completion
January 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2007
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 4, 2000
Actual (reported)February 2001
Date type not reportedThis date has not been verified as actual or estimated.
May 29, 2003
Actual (reported)January 2005
Actual (reported)January 2007
Actual (reported)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
Up to 6 months
Quality of life
Up to 6 months
Patients receive oral donepezil daily and vitamin E twice daily. 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.
Patients receive oral placebo twice daily. 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.
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016, United States
Siouxland Hematology-Oncology
Jatoi A, Kahanic SP, Frytak S, Schaefer P, Foote RL, Sloan J, Petersen RC. Donepezil and vitamin E for preventing cognitive dysfunction in small cell lung cancer patients: preliminary results and suggestions for future study designs. Support Care Cancer. 2005 Jan;13(1):66-9. doi: 10.1007/s00520-004-0696-0. Epub 2004 Oct 9.
Aminah Jatoi, MD
Mayo Clinic
9 participants (actual enrollment reported by the registry).
First Submitted
October 4, 2000
First Posted
May 29, 2003
Study Start
February 2001
Date type not reportedThis date has not been verified as actual or estimated.
Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell Lung Cancer
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Sioux City, Iowa, 51101-1733, United States
CCOP - Wichita
Wichita, Kansas, 67214-3882, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Medcenter One Health System
Bismarck, North Dakota, 58501, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104, United States
Primary Completion
January 2005
Actual (reported)Study Completion
January 2007
Actual (reported)Last Updated
July 13, 2016
Record last verified: 2016-07
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