Lycopene in Preventing Prostate Cancer in Healthy Participants

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093561
• Other study ID #: UIC-2004-0040
• Secondary ID: CDR0000389223
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2004
• Last updated: June 25, 2013
• Start date: August 2004
• Est. completion date: February 2006

Study information

• Verified date: November 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• lycopene

Locations

Country	Name	City	State
United States	University of Illinois at Chicago Cancer Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity by blood chemistries and patient histories at 4 weeks after treatment			Yes
Primary	Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment			No
Secondary	Define dose range by blood lycopene concentrations at 4 weeks after treatment			No