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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 Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about 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 website committed 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 health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts 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 permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance 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 typically receive the most expert healthcare available 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. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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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
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Fargo, North Dakota, 58122
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Jacksonville, Florida, 32224
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Wichita, Kansas, 67214-3882
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Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
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CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
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Medcenter One Health System
Bismark, North Dakota, 58501
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Rochester, Minnesota, 55905
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CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
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Rapid City, South Dakota, 57709
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Pittsburgh, Pennsylvania, 15212-4772
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
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CCOP - Carle Cancer Center
Urbana, Illinois, 61801
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CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
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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 Psychosocial Effects/treatment Studies:
1. BBR 3464 in Treating Patients With Metastatic Small Cell Lung Cancer That Has Not Responded to Previous Treatment
2. Interferon alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
3. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
4. Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
5. Radiolabeled SMT-487 in Treating Patients With Refractory Small Cell Lung Cancer or Metastatic Breast Cancer
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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
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