Lycopene in Preventing Prostate Cancer in Healthy Participants
- Conditions
- Prostate Cancer
- Registration Number
- NCT00093561
- Lead Sponsor
- University of Illinois at Chicago
- Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. The dietary supplement lycopene may prevent the development of prostate cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants.
- Detailed Description
OBJECTIVES:
* Determine the toxicity and safety of lycopene supplementation as chemoprevention for prostate cancer in healthy participants.
* Determine the pharmacokinetics of this agent in these participants.
* Determine the dose range of this agent in these participants.
OUTLINE: This is a dose-escalation study.
Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1.
Cohorts of 5 participants receive escalating doses of lycopene until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 participants experience dose-limiting toxicity.
Participants are evaluated periodically for 28 days.
PROJECTED ACCRUAL: A total of 25 participants will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Toxicity by blood chemistries and patient histories at 4 weeks after treatment Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment
- Secondary Outcome Measures
Name Time Method Define dose range by blood lycopene concentrations at 4 weeks after treatment
Trial Locations
- Locations (1)
University of Illinois at Chicago Cancer Center
🇺🇸Chicago, Illinois, United States