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Lycopene in Preventing Prostate Cancer in Healthy Participants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00322114
First received: May 3, 2006
Last updated: July 7, 2009
Last verified: July 2009
History of Changes
  Purpose

RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming.

PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.


Condition Intervention
Prostate Cancer
 Dietary Supplement: lycopene
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: Mechanism of Prostate Cancer Prevention by Lycopene

Resource links provided by NLM:

Drug Information available for: Lycopene
U.S. FDA Resources

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

Primary Outcome Measures:
  • Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2006
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
 Dietary Supplement: lycopene
Given orally
Experimental: Arm II
Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
 Dietary Supplement: lycopene
Given orally
Placebo Comparator: Arm III
Participants receive oral placebo twice daily for 3 weeks.
 Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen (PSA) in healthy participants.

Secondary

  • Determine whether lycopene reduces oxidative stress in these participants, as indicated by lipid peroxidation assay.
  • Determine whether a 21-day washout period is sufficient to return lycopene, PSA, and lipid peroxidation products to baseline.

OUTLINE: This is a randomized, placebo-controlled study. Participants are randomized to 1 of 3 treatment arms.

  • Arm I: Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
  • Arm II: Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
  • Arm III: Participants receive oral placebo twice daily for 3 weeks. Urine and blood samples are collected on days 0, 21, and 42.

PROJECTED ACCRUAL: A total of 150 participants will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Healthy participants
  • No existing prostate disease

PATIENT CHARACTERISTICS:

  • Able to supply blood and urine samples
  • Able to answer demographic and dietary recall questionnaires
  • No hospital inpatients
  • Not allergic to tomatoes or tomato products
  • Not abusing alcohol or non-prescribed drugs
  • No existing gastrointestinal disease or cancer

PRIOR CONCURRENT THERAPY:

  • At least 2 weeks since prior lycopene (in supplement form)
  • No concurrent participation in another clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322114

Locations
United States, Illinois
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center     312-355-3046        
Sponsors and Collaborators
University of Illinois
National Cancer Institute (NCI)
Investigators
Principal Investigator: Richard B. van Breemen, PhD University of Illinois
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00322114     History of Changes
Other Study ID Numbers: CDR0000468031, UIC-2004-0217
Study First Received: May 3, 2006
Last Updated: July 7, 2009
Health Authority: Unspecified

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 May 16, 2013