Lycopene in Healthy Male Participants

Completed · Phase 1

Conditions studied: Healthy, no Evidence of Disease, Prostate Cancer

In brief

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

Key facts

Study ID

NCT00450957

Run by

National Cancer Institute (NCI)

People needed

20

Starts

2006-10-01

Expected to finish

2007-11-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy volunteers judged to be in good medical condition based on history and physical exam
• Karnofsky performance status 100%
• AST and ALT ≤ 75 IU/L
• Bilirubin ≤ 2.0 mg/dL
• Creatinine ≤ 1.5 mg/dL
• Hemoglobin ≥ 13.0 g/dL
• WBC ≥ 4,000/mm³
• Platelet count ≥ 150,000/mm³ and ≤ 400,000/mm³
• Must be within height and weight standards identified by Metropolitan Life scales
• Nonsmoker (for ≥ 3 months)
• No history of alcohol abuse
• No history of gastrointestinal malabsorption or other condition that could affect drug absorption
• No history of a psychiatric condition
• No chronic medical condition
• No active history of any of the following:
• Cancer
• Liver disease
• Cardiovascular disease
• Renal disease
• Diabetes mellitus
• Other illnesses that, in the opinion of the investigator, could represent a threat for the participants life
• No allergy to tomato-based products
• No lycopene in the diet for ≥ 14 days
• At least 4 weeks since prior and no other concurrent experimental medications
• No concurrent participation in another experimental study

Where it is running

• University of Illinois — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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