Completed

NCT Number: NCT00255775

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.

Completed

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan