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.

Condition	Intervention
Non-Small Cell Lung Cancer Small Cell Lung Cancer	Drug: broccoli sprout extract  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer  Procedure: complementary and alternative therapy  Procedure: dietary intervention  Procedure: herbal medicine / botanical therapy  Procedure: nutritional supplementation

Further study details as provided by National Cancer Institute (NCI):

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00255775

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States; Recruiting

Study chairs or principal investigators

Julie Brahmer, MD,  Study Chair,  Sidney Kimmel Comprehensive Cancer Center   

Study ID Numbers:  CDR0000450158; JHOC-J0427; JHOC-04051801
Last Updated:  June 7, 2006
Record first received:  November 18, 2005
ClinicalTrials.gov Identifier:  NCT00255775
Health Authority: United States: Federal Government

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