Broccoli Sprout Extract in Preventing Lung Cancer in Smokers - Tabular View

Tracking Information

First Received Date ^ICMJE

November 18, 2005

Last Updated Date

February 26, 2009

Start Date ^ICMJE

January 2005

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00255775 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

Official Title ^ICMJE

Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Open Label

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00255775

Responsible Party

Study ID Numbers ^ICMJE

CDR0000450158, JHOC-J0427, JHOC-04051801

Study Sponsor ^ICMJE

Sidney Kimmel Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Julie Brahmer, MD

Sidney Kimmel Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP