Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Prevention Active Over 18 NCI JHOC-J0427 JHOC-04051801, NCT00255775

Special Category: SPORE trial

Objectives

Primary

1. Evaluate the effect of broccoli sprout extract on levels of DNA adducts in participants who smoke.
2. Determine the effectiveness of broccoli sprout extract in reducing tobacco-carcinogen induced DNA adducts in these participants.

Secondary

1. Determine the effects of broccoli sprout extract on markers of the Nrf2 pathway in these participants.
2. Determine the effectiveness of broccoli sprout extract, in increasing the activity of the Nrf2 pathway, in these participants.
3. Evaluate the feasibility of using lymphocytes and buccal cells to monitor DNA adducts and changes in the Nrf2 pathway in these participants.

Entry Criteria

Disease Characteristics:

• Current smoker with ≥ 30 pack-year history of smoking

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

Patient Characteristics:

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC > 4,000/mm³
• Platelet count > 100,000/mm³

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

Expected Enrollment

A total of 70 participants will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Julie Brahmer, MD, Protocol chair		Ph: 410-502-7159

U.S.A.
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu

Registry Information
Official Title		Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers
Trial Start Date		2005-01-20
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00255775
Date Submitted to PDQ		2005-09-13
Information Last Verified		2007-01-15
NCI Grant/Contract Number		P50-CA058184, P30-CA06973