Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

Study Overview
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Brief Summary
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RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of broccoli sprout extract may prevent lung cancer. PURPOSE: This clinical trial is studying how well broccoli sprout extract works in preventing lung cancer in smokers.

Detailed Description
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OBJECTIVES: Primary Evaluate the effect of broccoli sprout extract on levels of DNA adducts in participants who smoke. Determine the effectiveness of broccoli sprout extract in reducing tobacco-carcinogen induced DNA adducts in these participants. Secondary Determine the effects of broccoli sprout extract on markers of the Nrf2 pathway in these participants. Determine the effectiveness of broccoli sprout extract, in increasing the activity of the Nrf2 pathway, in these participants. Evaluate the feasibility of using lymphocytes and buccal cells to monitor DNA adducts and changes in the Nrf2 pathway in these participants. OUTLINE: Participants are stratified according to GST genotypic polymorphism (M1 vs T1). Participants receive oral broccoli sprout extract daily for 3 weeks. Participants keep a daily diary of their eating and smoking habits for 3 weeks before, during, and for 3 weeks after study treatment. They must continue to smoke during the study, but are encouraged to quit after completing the study treatment. PROJECTED ACCRUAL: A total of 70 participants will be accrued for this study.

Official Title
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Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers

Conditions
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Lung Cancer

Intervention / Treatment
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* Dietary Supplement: broccoli sprout extract
* Procedure: complementary or alternative medicine procedure


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Current smoker with ≥ 30 pack-year history of smoking PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic WBC > 4,000/mm^3 Platelet count > 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL Renal Creatinine ≤ 1.5 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile participants must use effective contraception No other medical condition that would preclude study treatment or compliance No gastrointestinal condition that would affect absorption, preclude taking oral medication, or necessitate IV alimentation PRIOR CONCURRENT THERAPY: Surgery No prior surgery affecting absorption Other More than 6 weeks since prior vitamins, herbal supplements, non-steroidal anti-inflammatory drugs, or antibiotics No concurrent dietary intake of cruciferous vegetables

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: broccoli sprout extract|nan|
|Procedure: complementary or alternative medicine procedure|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, small cell lung cancer