Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

Johns Hopkins Medicine

Status: Completed

Conditions: Lung Cancer

Treatments: Procedure: complementary or alternative medicine procedure; Dietary Supplement: broccoli sprout extract

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00255775

JHOC-J0427, CDR0000450158

P30CA006973 (U.S. NIH Grant/Contract)

JHOC-J0427

JHOC-04051801

P50CA058184 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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