Back to resultsLycopene in Preventing Prostate Cancer in Healthy Participants
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lycopene
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer
Eligibility Criteria
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
Sites / Locations
- University of Illinois Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Arm I
Arm II
Arm III
Arm Description
Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
Participants receive oral placebo twice daily for 3 weeks.
Outcomes
Primary Outcome Measures
Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene
Secondary Outcome Measures
Full Information
NCT ID
NCT00322114
First Posted
May 3, 2006
Last Updated
September 19, 2013
Sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00322114
Brief Title
Lycopene in Preventing Prostate Cancer in Healthy Participants
Official Title
Mechanism of Prostate Cancer Prevention by Lycopene
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
Detailed Description
OBJECTIVES:
Primary
Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen (PSA) in healthy participants.
Secondary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
Arm Title
Arm III
Arm Type
Placebo Comparator
Arm Description
Participants receive oral placebo twice daily for 3 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
lycopene
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B. van Breemen, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7243
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Office - University of Illinois Cancer Center
Phone
312-355-3046
12. IPD Sharing Statement
Learn more about this trial
Lycopene in Preventing Prostate Cancer in Healthy Participants
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