Status:
COMPLETED
Lycopene in Preventing Prostate Cancer in Healthy Participants
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 c...
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 par...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00093561
Start Date
August 1 2004
End Date
February 1 2006
Last Update
June 26 2013
Active Locations (1)
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1
University of Illinois at Chicago Cancer Center
Chicago, Illinois, United States, 60612