Clinical trial NCT00255775: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: non-small cell lung cancer
small cell lung cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-11-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Julie Brahmer, MD
role: STUDY_CHAIR
References: