Lycopene in Healthy Male Participants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00450957
First received: March 20, 2007
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Healthy, no Evidence of Disease
Prostate Cancer
Dietary Supplement: lycopene
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Safety according to NCI CTC version 3.0 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2006
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: lycopene
Given orally
Other Names:
  • all-trans-Lycopene
  • Lyc-O-Mato
  • LYCO
  • psi,psi-Carotene
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
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
Dietary Supplement: lycopene
Given orally
Other Names:
  • all-trans-Lycopene
  • Lyc-O-Mato
  • LYCO
  • psi,psi-Carotene
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450957

Locations
United States, Illinois
University of Illinois
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Investigators
Principal Investigator: Keith Rodvold University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00450957     History of Changes
Other Study ID Numbers: NCI-2012-02709, UIC-2006-0853, CDR0000536181, N01CN85081
Study First Received: March 20, 2007
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014