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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|