Lycopene in Healthy Male Participants

NCT ID: NCT00450957

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-11-30

Brief Summary

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.

Detailed Description

OBJECTIVES:

I. Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants.

II. Compare the pharmacokinetics of 2 different doses of this drug in these participants.

III. 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.

Conditions

Healthy, no Evidence of Disease; Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm I (high-dose lycopene)

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.

Group Type: EXPERIMENTAL

lycopene

Intervention Type: DIETARY_SUPPLEMENT

Given orally

pharmacological study

Intervention Type: OTHER

Correlative studies

Arm II (low-dose lycopene)

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

Group Type: EXPERIMENTAL

lycopene

Intervention Type: DIETARY_SUPPLEMENT

Given orally

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

lycopene

Given orally

Intervention Type: DIETARY_SUPPLEMENT

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

all-trans-Lycopene; Lyc-O-Mato; LYCO; psi,psi-Carotene; pharmacological studies

Eligibility Criteria

Inclusion Criteria

• 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
• No concurrent use of regular prescription medication or over-the-counter medications
• No concurrent vitamin, mineral, or herbal supplements

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Rodvold

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NCI-2012-02709

Identifier Type: -

Identifier Source: org_study_id

UIC-2006-0853

Identifier Type: -

Identifier Source: secondary_id

CDR0000536181

Identifier Type: -

Identifier Source: secondary_id

N01CN85081

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id