Lycopene in Preventing Prostate Cancer in Healthy Participants

University of Illinois

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Dietary Supplement: lycopene

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00093561

UIC-2004-0040

CDR0000389223 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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