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Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Evaluation of the Biological Effects of Broccoli Sprout Extract in Smokers


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Prevention

Principal Investigator

Julie Brahmer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

JHOC-J0427, CDR0000450158

NCT ID:

NCT00255775

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • Lung Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410