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Lycopene in Healthy Male Participants

2014-08-27 03:39:30 | BioPortfolio

Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants.

Description

OBJECTIVES:

- 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.

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Conditions

Healthy, no Evidence of Disease

Intervention

dietary intervention, lycopene, pharmacological study, preventative dietary intervention

Location

University of Illinois Cancer Center
Chicago
Illinois
United States
60612-7243

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:30-0400

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