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PURPOSE: This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants.
- Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants.
- Compare the pharmacokinetics of 2 different doses of this drug in these participants.
- Determine the toxicity and pharmacokinetics needed to proceed to a large phase II/III study in men at high risk for prostate cancer.
OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.
- Arm II: Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.
Treatment continues in the absence of unacceptable toxicity.
Participants adhere to dietary restrictions for 2 weeks at baseline, 2 weeks during study treatment, and 2 weeks during pharmacokinetic sampling.
Blood samples are collected periodically at baseline and during study treatment for pharmacokinetic studies.
PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.
Allocation: Randomized, Primary Purpose: Prevention
Healthy, no Evidence of Disease
dietary intervention, lycopene, pharmacological study, preventative dietary intervention
University of Illinois Cancer Center
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:39:30-0400
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