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Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer Clinical research trials and Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer. Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer  Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer
Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer
For Condition: psychosocial effects/treatment,limited stage small cell lung cancer,Depression,Recurrent Small Cell Lung Cancer,radiation toxicity,Delirium,extensive stage small cell lung cancer,Quality of Life
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Determine the toxicity of donepezil and vitamin E in these patients. III. Determine whether preserved cognitive function favorably impacts quality of life in these patients. IV. Determine the natural history of cognitive decline in these patients after cancer treatment. V. 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. PROTOCOL 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. PROJECTED ACCRUAL: A total of 104 patients (52 per arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: - See Disease Characteristics - No concurrent anticancer chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified 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 --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Not specified 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AminahJatoi, Study Chair, North Central Cancer Treatment Group
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Additional Information:
Study ID Numbers: CDR0000068206; NCI-P00-0169,NCCTG-N99C5
Study Start Date: February 2001
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006349
Other Limited Stage Small Cell Lung Cancer Studies:
1. Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
2. Zinc Sulfate in Preventing Loss of Sense of Taste in Patients Undergoing Radiation Therapy for Head and Neck Cancer
3. Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
4. Glutamine in Treating Mucositis Caused by Radiation Therapy in Patients With Newly Diagnosed Cancer of the Mouth or Throat
5. Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
Related Studies:
Other limited stage small cell lung cancer Clinical Trials
Other South Dakota Clinical Trials
Other Rapid City Clinical Trials
Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer
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