Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-03 @ 7:33 PM
Study NCT ID:
NCT00093561
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2004-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lycopene in Preventing Prostate Cancer in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077276', 'term': 'Lycopene'}], 'ancestors': [{'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'PREVENTION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2004-10-06', 'studyFirstSubmitQcDate': '2004-10-07', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-10-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity by blood chemistries and patient histories at 4 weeks after treatment'}, {'measure': 'Pharmacokinetics by blood lycopene concentrations at 4 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'Define dose range by blood lycopene concentrations at 4 weeks after treatment'}]}, 'conditionsModule': {'keywords': ['prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the toxicity and safety of lycopene supplementation as chemoprevention for prostate cancer in healthy participants.\n* Determine the pharmacokinetics of this agent in these participants.\n* Determine the dose range of this agent in these participants.\n\nOUTLINE: This is a dose-escalation study.\n\nParticipants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1.\n\nCohorts 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.\n\nParticipants are evaluated periodically for 28 days.\n\nPROJECTED ACCRUAL: A total of 25 participants will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Healthy participants in good medical condition\n\n * No chronic medical conditions\n * No regular use of prescription medications\n * No evidence of psychiatric disorder\n * Non-smoker\n\n * Former smokers allowed provided they have not smoked within the past 3 months\n * No history of alcohol abuse\n* Serum lycopene concentration \\< 700 nM\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 45\n\nPerformance status\n\n* Karnofsky 100%\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Hemoglobin ≥ 13.0 g/dL\n* WBC ≥ 4,000/mm\\^3\n* Platelet count 150,000-400,000/mm\\^3\n\nHepatic\n\n* AST and ALT ≤ 75 U/L\n* Bilirubin ≤ 2.0 mg/dL\n* No liver disease\n\nRenal\n\n* Creatinine ≤ 1.5 mg/dL\n* No renal disease\n\nCardiovascular\n\n* No cardiovascular disease\n* No abnormal EKG\n\nOther\n\n* Within 15% of ideal body weight\n* No history of gastrointestinal malabsorption or other condition that would preclude drug absorption\n* No alcohol consumption within the past 72 hours\n* No allergy to tomato-based products\n* No history of cancer\n* No diabetes mellitus\n* No other illness that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 4 weeks since prior experimental drugs\n* More than 14 days since prior prescription drugs\n* No concurrent participation in another experimental trial\n* No concurrent prescription drugs'}, 'identificationModule': {'nctId': 'NCT00093561', 'briefTitle': 'Lycopene in Preventing Prostate Cancer in Healthy Participants', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'UIC-2004-0040'}, 'secondaryIdInfos': [{'id': 'CDR0000389223', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'lycopene', 'type': 'DIETARY_SUPPLEMENT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Keith A. Rodvold', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}