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)
3 other identifiers
interventional
9
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2001
Longer than P75 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2000
CompletedStudy Start
First participant enrolled
February 1, 2001
CompletedFirst Posted
Study publicly available on registry
May 29, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedJuly 13, 2016
July 1, 2016
3.9 years
October 4, 2000
July 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Quality of life
Up to 6 months
Study Arms (2)
donepezil + vitamin E
EXPERIMENTALPatients 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.
placebo
PLACEBO COMPARATORPatients 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.
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (15)
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
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
Related Publications (1)
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.
PMID: 15480814RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aminah Jatoi, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2000
First Posted
May 29, 2003
Study Start
February 1, 2001
Primary Completion
January 1, 2005
Study Completion
January 1, 2007
Last Updated
July 13, 2016
Record last verified: 2016-07