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Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

This study is currently recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Broccoli Sprout Extract in Preventing Lung Cancer in Smokers
Official Title  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  Interventional
Study Design  Prevention, Open Label
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Lung Cancer
Intervention  Drug: broccoli sprout extract
Procedure: complementary or alternative medicine procedure
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  70
Start Date  January 2005
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00255775
Organization ID CDR0000450158
Secondary IDs †† JHOC-J0427, JHOC-04051801
Study Sponsor  Sidney Kimmel Comprehensive Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Julie Brahmer, MD     Sidney Kimmel Comprehensive Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date January 2007
First Received Date  November 18, 2005
Last Updated Date July 25, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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