Broccoli Sprout Extract in Preventing Lung Cancer in Smokers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00255775|
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : August 9, 2010
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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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Dietary Supplement: broccoli sprout extract Procedure: complementary or alternative medicine procedure||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||May 2009|
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Current smoker with ≥ 30 pack-year history of smoking
- ECOG 0-2
- Not specified
- WBC > 4,000/mm^3
- Platelet count > 100,000/mm^3
- Bilirubin ≤ 1.5 mg/dL
- Creatinine ≤ 1.5 mg/dL
- 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:
- No prior surgery affecting absorption
- More than 6 weeks since prior vitamins, herbal supplements, non-steroidal anti-inflammatory drugs, or antibiotics
- No concurrent dietary intake of cruciferous vegetables
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 at Johns Hopkins|
|Other Study ID Numbers:||
P50CA058184 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
|First Posted:||November 21, 2005 Key Record Dates|
|Last Update Posted:||August 9, 2010|
|Last Verified:||August 2010|
non-small cell lung cancer
small cell lung cancer
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases