- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00255775
Broccoli Sprout Extract in Preventing Lung Cancer in Smokers
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231-2410
- Sidney kimmel comprehensive cancer center at johns hopkins
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Julie Brahmer, MD, Sidney kimmel comprehensive cancer center at johns hopkins
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JHOC-J0427, CDR0000450158
- P30CA006973 (U.S. NIH Grant/Contract)
- P50CA058184 (U.S. NIH Grant/Contract)
- JHOC-J0427
- JHOC-04051801
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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