Lung Cancer Clinical Trial
Official title:
Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers
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.
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.
;
Masking: Open Label, Primary Purpose: Prevention
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