Lycopene in Healthy Male Participants - Full Text View

Sponsors and Collaborators:	University of Illinois National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00450957

Purpose

RATIONALE: 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.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants.

Condition	Intervention	Phase
Healthy, no Evidence of Disease Prostate Cancer	Dietary Supplement: dietary intervention Dietary Supplement: lycopene Other: pharmacological study Other: preventative dietary intervention	Phase I

MedlinePlus related topics: Cancer Dietary Supplements Diets Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized
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

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

Primary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Safety [ Designated as safety issue: Yes ]
Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2006
Estimated Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants.
Compare the pharmacokinetics of 2 different doses of this drug in these participants.
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

DISEASE CHARACTERISTICS:

Healthy volunteers judged to be in good medical condition based on history and physical exam

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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

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

Locations

United States, Illinois
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243

Sponsors and Collaborators

University of Illinois

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Keith A. Rodvold

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

Study ID Numbers:	CDR0000536181, UIC-2006-0853
Study First Received:	March 20, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00450957 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

prostate cancer
healthy, no evidence of disease

Study placed in the following topic categories:

Anticarcinogenic Agents
Radiation-Protective Agents
Antioxidants
Prostatic Diseases
Genital Neoplasms, Male

Lycopene
Urogenital Neoplasms
Healthy
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anticarcinogenic Agents
Radiation-Protective Agents
Antioxidants
Genital Neoplasms, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Lycopene
Physiological Effects of Drugs

Urogenital Neoplasms
Genital Diseases, Male
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009