Lycopene in Preventing Prostate Cancer in Healthy Participants
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.
|Study Design:||Primary Purpose: Prevention|
|Official Title:||Phase I Single Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 45 Years of Age|
- Toxicity by blood chemistries and patient histories at 4 weeks after treatment [ Designated as safety issue: Yes ]
- Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment [ Designated as safety issue: No ]
- Define dose range by blood lycopene concentrations at 4 weeks after treatment [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Study Completion Date:||February 2006|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093561
|United States, Illinois|
|University of Illinois at Chicago Cancer Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Keith A. Rodvold||University of Illinois at Chicago|