Lycopene in Preventing Prostate Cancer in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT00093561|
Recruitment Status : Completed
First Posted : October 8, 2004
Last Update Posted : June 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: lycopene||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Study Start Date :||August 2004|
|Actual Study Completion Date :||February 2006|
- Toxicity by blood chemistries and patient histories at 4 weeks after treatment
- Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment
- Define dose range by blood lycopene concentrations at 4 weeks after treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|