Lycopene in Healthy Male Participants

NCT00450957 | Completed Phase 1

• 4 other identifiers: NCI-2012-02709UIC-2006-0853CDR0000536181N01CN85081
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy, no Evidence of Disease; Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0

  2 weeks

• Safety according to NCI CTC version 3.0

  12 weeks

• Pharmacokinetics

  At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours

Study Arms (2)

Arm I (high-dose lycopene)

EXPERIMENTAL

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; Other: pharmacological study

Arm II (low-dose lycopene)

EXPERIMENTAL

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; Other: pharmacological study

Interventions

lycopene DIETARY_SUPPLEMENT

Given orally

Also known as: all-trans-Lycopene, Lyc-O-Mato, LYCO, psi,psi-Carotene

Arm I (high-dose lycopene); Arm II (low-dose lycopene)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I (high-dose lycopene); Arm II (low-dose lycopene)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Illinois

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lycopene

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Keith Rodvold

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: October 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 15, 2015

Record last verified: 2013-04

Locations

US (1)