Lycopene in Preventing Prostate Cancer in Healthy Participants

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00093561
First received: October 6, 2004
Last updated: June 25, 2013
Last verified: November 2006
  Purpose

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 Intervention Phase
Prostate Cancer
Dietary Supplement: lycopene
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Prevention
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Toxicity by blood chemistries and patient histories at 4 weeks after treatment [ Designated as safety issue: Yes ]
  • Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Define dose range by blood lycopene concentrations at 4 weeks after treatment [ Designated as safety issue: No ]

Study Start Date: August 2004
Study Completion Date: February 2006
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Healthy participants in good medical condition

    • No chronic medical conditions
    • No regular use of prescription medications
    • No evidence of psychiatric disorder
    • Non-smoker

      • Former smokers allowed provided they have not smoked within the past 3 months
    • No history of alcohol abuse
  • Serum lycopene concentration < 700 nM

PATIENT CHARACTERISTICS:

Age

  • 18 to 45

Performance status

  • Karnofsky 100%

Life expectancy

  • Not specified

Hematopoietic

  • Hemoglobin ≥ 13.0 g/dL
  • WBC ≥ 4,000/mm^3
  • Platelet count 150,000-400,000/mm^3

Hepatic

  • AST and ALT ≤ 75 U/L
  • Bilirubin ≤ 2.0 mg/dL
  • No liver disease

Renal

  • Creatinine ≤ 1.5 mg/dL
  • No renal disease

Cardiovascular

  • No cardiovascular disease
  • No abnormal EKG

Other

  • Within 15% of ideal body weight
  • No history of gastrointestinal malabsorption or other condition that would preclude drug absorption
  • No alcohol consumption within the past 72 hours
  • No allergy to tomato-based products
  • No history of cancer
  • No diabetes mellitus
  • No other illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 4 weeks since prior experimental drugs
  • More than 14 days since prior prescription drugs
  • No concurrent participation in another experimental trial
  • No concurrent prescription drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093561

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00093561     History of Changes
Other Study ID Numbers: UIC-2004-0040, CDR0000389223
Study First Received: October 6, 2004
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
prostate cancer

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 April 17, 2014