Lycopene in Healthy Male Participants

National Cancer Institute (NCI)

Status and phase: Completed; Phase 1

Conditions: Healthy, no Evidence of Disease; Prostate Cancer

Treatments: Dietary Supplement: lycopene; Other: pharmacological study

Study type: Interventional

Funder types: NIH

Identifiers

NCT00450957

N01CN85081 (Other Grant/Funding Number)

NCI-2012-02709

UIC-2006-0853

CDR0000536181

Details and patient eligibility

About

This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.

Full description

OBJECTIVES:

I. Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants.

II. Compare the pharmacokinetics of 2 different doses of this drug in these participants.

III. Determine the toxicity and pharmacokinetics needed to proceed to a large phase II/III study in men at high risk for prostate cancer.

OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2 treatment arms.

Arm I: Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.

Arm II: Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.

Treatment continues in the absence of unacceptable toxicity. Participants adhere to dietary restrictions for 2 weeks at baseline, 2 weeks during study treatment, and 2 weeks during pharmacokinetic sampling.

Blood samples are collected periodically at baseline and during study treatment for pharmacokinetic studies.

PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy volunteers judged to be in good medical condition based on history and physical exam

• Karnofsky performance status 100%

• AST and ALT ≤ 75 IU/L

• Bilirubin ≤ 2.0 mg/dL

• Creatinine ≤ 1.5 mg/dL

• Hemoglobin ≥ 13.0 g/dL

• WBC ≥ 4,000/mm³

• Platelet count ≥ 150,000/mm³ and ≤ 400,000/mm³

• Must be within height and weight standards identified by Metropolitan Life scales

• Nonsmoker (for ≥ 3 months)

• No history of alcohol abuse

• No history of gastrointestinal malabsorption or other condition that could affect drug absorption

• No history of a psychiatric condition

• No chronic medical condition

• No active history of any of the following:

  • Cancer
  • Liver disease
  • Cardiovascular disease
  • Renal disease
  • Diabetes mellitus
  • Other illnesses that, in the opinion of the investigator, could represent a threat for the participants life

• No allergy to tomato-based products

• No lycopene in the diet for ≥ 14 days

• At least 4 weeks since prior and no other concurrent experimental medications

• No concurrent participation in another experimental study

• No concurrent use of regular prescription medication or over-the-counter medications

• No concurrent vitamin, mineral, or herbal supplements

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Arm I (high-dose lycopene)

Experimental group

Description:

Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.

Treatment:

Other: pharmacological study

Dietary Supplement: lycopene

Arm II (low-dose lycopene)

Experimental group

Description:

Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days

Treatment:

Other: pharmacological study

Dietary Supplement: lycopene