Recruiting

LycopeneLycopene in Preventing Prostate Cancer in Healthy Participants

Sponsor:

University of Illinois at Chicago

Code:

NCT00322114

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

lycopene

placebo

Study Details

Brief summary:

RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming.

PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.

Conditions

Prostate Cancer

Study ID

NCT00322114

Start date

Feb, 2006

Status verified date

Jul, 2009

Primary completion date

Feb, 2009

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

DISEASE CHARACTERISTICS:

Healthy participants
No existing prostate disease

PATIENT CHARACTERISTICS:

Able to supply blood and urine samples
Able to answer demographic and dietary recall questionnaires
No hospital inpatients
Not allergic to tomatoes or tomato products
Not abusing alcohol or non-prescribed drugs
No existing gastrointestinal disease or cancer

PRIOR CONCURRENT THERAPY:

At least 2 weeks since prior lycopene (in supplement form)
No concurrent participation in another clinical trial

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm I

Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.

experimental: Arm II

Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.

placebo comparator: Arm III

Participants receive oral placebo twice daily for 3 weeks.

Interventions

lycopene

Given orally

placebo

Given orally

Primary outcome measure

Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene [ Time Frame: undefined ]

Central Contacts and Locations

Locations

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612-7243

Contacts

Clinical Trial Office - University of Illinois Cancer Center

312-355-3046

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Sep 20, 2013

Last verified

Jul, 2009

Keywords

prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2013-09-20.