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Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
broccoli sprout extract
complementary or alternative medicine procedure
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring non-small cell lung cancer, small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 18, 2005
Last Updated
August 5, 2010
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00255775
Brief Title
Broccoli Sprout Extract in Preventing Lung Cancer in Smokers
Official Title
Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
non-small cell lung cancer, small cell lung cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
broccoli sprout extract
Intervention Type
Procedure
Intervention Name(s)
complementary or alternative medicine procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Brahmer, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

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Broccoli Sprout Extract in Preventing Lung Cancer in Smokers

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