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Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00255775
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : August 9, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lung Cancer Dietary Supplement: broccoli sprout extract Procedure: complementary or alternative medicine procedure Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers
Study Start Date : January 2005
Actual Primary Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255775


Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Study Chair: Julie Brahmer, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
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ClinicalTrials.gov Identifier: NCT00255775    
Obsolete Identifiers: NCT00090350
Other Study ID Numbers: JHOC-J0427, CDR0000450158
P50CA058184 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0427
JHOC-04051801
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: August 9, 2010
Last Verified: August 2010
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
non-small cell lung cancer
small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases