NCT00255775

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Last Updated

August 9, 2010

Status Verified

August 1, 2010

Enrollment Period

4.3 years

First QC Date

November 18, 2005

Last Update Submit

August 5, 2010

Conditions

Lung Cancer

Keywords

non-small cell lung cancersmall cell lung cancer

Interventions

broccoli sprout extractDIETARY_SUPPLEMENT
complementary or alternative medicine procedurePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Julie Brahmer, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 21, 2005

Study Start

January 1, 2005

Primary Completion

May 1, 2009

Last Updated

August 9, 2010

Record last verified: 2010-08

Locations

US(1)