Lycopene in Healthy Male Participants
Primary Purpose
Healthy, no Evidence of Disease, Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lycopene
pharmacological study
Sponsored by
About this trial
This is an interventional prevention trial for Healthy, no Evidence of Disease
Eligibility 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
Sites / Locations
- University of Illinois
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm I (high-dose lycopene)
Arm II (low-dose lycopene)
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0
Safety according to NCI CTC version 3.0
Pharmacokinetics
Secondary Outcome Measures
Full Information
NCT ID
NCT00450957
First Posted
March 20, 2007
Last Updated
April 14, 2015
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00450957
Brief Title
Lycopene in Healthy Male Participants
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, no Evidence of Disease, Prostate Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (high-dose lycopene)
Arm Type
Experimental
Arm Description
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 Title
Arm II (low-dose lycopene)
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
lycopene
Other Intervention Name(s)
all-trans-Lycopene, Lyc-O-Mato, LYCO, psi,psi-Carotene
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Toxicity according to NCI Common Toxicity Criteria (CTC) version 3.0
Time Frame
2 weeks
Title
Safety according to NCI CTC version 3.0
Time Frame
12 weeks
Title
Pharmacokinetics
Time Frame
At baseline, at 12, 24, 36, 48, 72, 96, 120, 168, 216, 288, and 360 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Rodvold
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
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Lycopene in Healthy Male Participants
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