Lycopene in Preventing Prostate Cancer in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT00322114|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 4, 2006
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Dietary Supplement: lycopene Other: placebo|
- Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen (PSA) in healthy participants.
- Determine whether lycopene reduces oxidative stress in these participants, as indicated by lipid peroxidation assay.
- Determine whether a 21-day washout period is sufficient to return lycopene, PSA, and lipid peroxidation products to baseline.
OUTLINE: This is a randomized, placebo-controlled study. Participants are randomized to 1 of 3 treatment arms.
- Arm I: Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
- Arm II: Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
- Arm III: Participants receive oral placebo twice daily for 3 weeks. Urine and blood samples are collected on days 0, 21, and 42.
PROJECTED ACCRUAL: A total of 150 participants will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Official Title:||Mechanism of Prostate Cancer Prevention by Lycopene|
|Study Start Date :||February 2006|
|Estimated Primary Completion Date :||February 2009|
Experimental: Arm I
Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
Dietary Supplement: lycopene
Experimental: Arm II
Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
Dietary Supplement: lycopene
Placebo Comparator: Arm III
Participants receive oral placebo twice daily for 3 weeks.
- Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322114
|United States, Illinois|
|University of Illinois Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60612-7243|
|Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046|
|Principal Investigator:||Richard B. van Breemen, PhD||University of Illinois at Chicago|