NCT00006078

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of lycopene may be an effective way to prevent prostate cancer. PURPOSE: Phase I trial to study the effectiveness of lycopene in preventing prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2000

Typical duration for phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

June 26, 2013

Status Verified

December 1, 2004

First QC Date

August 3, 2000

Last Update Submit

June 25, 2013

Conditions

Prostate Cancer

Keywords

prostate cancer

Interventions

lycopeneDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Normal healthy males judged to be in good medical condition based on history and physical exam confirming the absence of chronic medical conditions * Baseline serum lycopene less than 600 nM PATIENT CHARACTERISTICS: Age: * 18 to 45 Performance status: * Karnofsky 100% Life expectancy: * Not specified Hematopoietic: * Hematologic function normal Hepatic: * Liver function normal * No hepatic disease Renal: * Kidney function normal * No renal disease Cardiovascular: * No hypertension requiring medication * No cardiovascular disease * Normal EKG Other: * No evidence of a psychiatric disorder * Must be within 15% of ideal body weight based on standard weight tables * No history of smoking within the past 3 months * At least 72 hours since prior alcohol consumption and no history of alcohol abuse * No history of gastrointestinal malabsorption or any other condition that could affect drug absorption * No allergy to tomato based products * No active malignancy at any site * No illness that would pose a threat or additional risk (e.g., thyroid disease, diabetes mellitus) PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 14 days since prior prescription drugs * No concurrent regular prescription medications * At least 30 days since other prior experimental drugs * No concurrent participation in any other experimental trial

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

Sponsors & Collaborators

Study Sites (1)

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lycopene

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Keith A. Rodvold

    University of Illinois at Chicago

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2000

First Posted

January 27, 2003

Study Start

June 1, 2000

Study Completion

January 1, 2005

Last Updated

June 26, 2013

Record last verified: 2004-12

Locations

US(1)