Lycopene in Healthy Male Participants

April 14, 2015 updated by: National Cancer Institute (NCI)

Phase I Multiple Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 55 Years of Age

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Correlative studies
Other Names:
  • pharmacological studies
Given orally
Other Names:
  • all-trans-Lycopene
  • Lyc-O-Mato
  • LYCO
  • psi,psi-Carotene
EXPERIMENTAL: 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
Correlative studies
Other Names:
  • pharmacological studies
Given orally
Other Names:
  • all-trans-Lycopene
  • Lyc-O-Mato
  • LYCO
  • psi,psi-Carotene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0
Time Frame: 2 weeks
2 weeks
Safety according to NCI CTC version 3.0
Time Frame: 12 weeks
12 weeks
Pharmacokinetics
Time Frame: At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours
At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Keith Rodvold, University of Illinois at Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

March 20, 2007

First Submitted That Met QC Criteria

March 20, 2007

First Posted (ESTIMATE)

March 22, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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