Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 13, 2016 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Supportive Care
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Dietary Supplement: vitamin E; Drug: donepezil hydrochloride; Other: placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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 PATIENT CHARACTERISTICS: Age:
- 18 and over Performance status:
- ECOG 0-2 Life expectancy:
- At least 12 weeks 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 PRIOR CONCURRENT THERAPY: Chemotherapy:
- See Disease Characteristics
- No concurrent anticancer chemotherapy 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- CCOP - Scottsdale Oncology ProgramScottsdale, Arizona
- Mayo ClinicJacksonville, Florida
- CCOP - Illinois Oncology Research AssociationPeoria, Illinois
- CCOP - Carle Cancer CenterUrbana, Illinois
- CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa
- CCOP - Iowa Oncology Research AssociationDes Moines, Iowa
- Siouxland Hematology-OncologySioux City, Iowa
- CCOP - WichitaWichita, Kansas
- Mayo Clinic Cancer CenterRochester, Minnesota
- CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska
- Medcenter One Health SystemBismarck, North Dakota
- CCOP - Merit Care HospitalFargo, North Dakota
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 13, 2016. Always confirm current availability with the study team.