Lycopene in Preventing Prostate Cancer in Healthy Participants

NCT00093561 | Completed Phase 1

• 2 other identifiers: UIC-2004-0040CDR0000389223
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (2)

• Toxicity by blood chemistries and patient histories at 4 weeks after treatment

• Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment

Secondary Outcomes (1)

• Define dose range by blood lycopene concentrations at 4 weeks after treatment

Interventions

lycopene DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Illinois at Chicago Cancer Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lycopene

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Keith A. Rodvold

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: August 1, 2004
• Study Completion: February 1, 2006
• Last Updated: June 26, 2013

Record last verified: 2006-11

Locations

US (1)