Lycopene in Preventing Prostate Cancer in Healthy Participants

NCT ID: NCT00093561

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2006-02-28

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.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: PREVENTION

Interventions

lycopene

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Principal Investigators

Keith A. Rodvold

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago Cancer Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

CDR0000389223

Identifier Type: REGISTRY

Identifier Source: secondary_id

UIC-2004-0040

Identifier Type: -

Identifier Source: org_study_id