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Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00255775
Enrollment
70
Registered
2005-11-21
Start date
2005-01-31
Completion date
Unknown
Last updated
2010-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

non-small cell lung cancer, small cell lung cancer

Brief summary

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

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.

Interventions

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead SponsorOTHER

Study design

Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026