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Lycopene in Preventing Prostate Cancer in Healthy Participants

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lycopene
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois at Chicago Cancer Center

Outcomes

Primary Outcome Measures

Toxicity by blood chemistries and patient histories at 4 weeks after treatment
Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment

Secondary Outcome Measures

Define dose range by blood lycopene concentrations at 4 weeks after treatment

Full Information

First Posted
October 6, 2004
Last Updated
June 25, 2013
Sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00093561
Brief Title
Lycopene in Preventing Prostate Cancer in Healthy Participants
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
lycopene
Primary Outcome Measure Information:
Title
Toxicity by blood chemistries and patient histories at 4 weeks after treatment
Title
Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment
Secondary Outcome Measure Information:
Title
Define dose range by blood lycopene concentrations at 4 weeks after treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith A. Rodvold
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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Lycopene in Preventing Prostate Cancer in Healthy Participants

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