Broccoli Sprout Extract in Preventing Lung Cancer 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.
|Lung Cancer||Dietary Supplement: broccoli sprout extract Procedure: complementary or alternative medicine procedure|
|Study Design:||Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers|
|Study Start Date:||January 2005|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255775
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Julie Brahmer, MD||Sidney Kimmel Comprehensive Cancer Center|