Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

NCT ID: NCT00255775

Last Updated: 2010-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

broccoli sprout extract

Intervention Type: DIETARY_SUPPLEMENT

complementary or alternative medicine procedure

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Principal Investigators

Julie Brahmer, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

P50CA058184

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JHOC-J0427

Identifier Type: -

Identifier Source: secondary_id

JHOC-04051801

Identifier Type: -

Identifier Source: secondary_id

JHOC-J0427, CDR0000450158

Identifier Type: -

Identifier Source: org_study_id

NCT00090350

Identifier Type: -

Identifier Source: nct_alias