Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-31 @ 5:04 AM
Study NCT ID:
NCT00020995
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2001-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'PREVENTION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-05', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2001-07-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage I prostate cancer', 'stage IIB prostate cancer', 'stage IIA prostate cancer', 'stage III prostate cancer', 'stage IV prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '19914662', 'type': 'RESULT', 'citation': 'Aronson WJ, Barnard RJ, Freedland SJ, Henning S, Elashoff D, Jardack PM, Cohen P, Heber D, Kobayashi N. Growth inhibitory effect of low fat diet on prostate cancer cells: results of a prospective, randomized dietary intervention trial in men with prostate cancer. J Urol. 2010 Jan;183(1):345-50. doi: 10.1016/j.juro.2009.08.104.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: A low-fat, high-fiber diet may slow the growth of prostate cancer.\n\nPURPOSE: Randomized phase II trial to compare the effectiveness of a low-fat, high-fiber diet with that of a standard diet in treating patients who have prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the inhibition of growth of human prostate cancer cell lines by serum from patients with prostate cancer before and after being fed a low fat, high fiber diet.\n* Determine the underlying mechanism through which a low fat, high fiber diet affects the growth of prostate cancer cell lines.\n* Determine whether a low fat, high fiber diet inhibits the growth of prostate cancer cell lines through androgen-dependent and/or androgen- independent mechanisms in these patients.\n* Determine the growth factors, hormones, and/or binding proteins that may be responsible for affecting the growth of prostate cancer cell lines in these patients.\n\nOUTLINE: This is a randomized study. Patients are randomized to 1 of 2 arms.\n\n* Arm I: Patients receive a low fat, high fiber diet daily for 3 weeks.\n* Arm II: Patients receive a control diet containing the standard amounts of fat and fiber.\n\nPROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within 6 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of adenocarcinoma of the prostate\n* Previously untreated and on watchful waiting\n* Medically able to receive dietary intervention\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 40 to 80\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* Must be willing to travel to UCLA 3 days a week for 4 weeks to obtain specially prepared foods\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* No concurrent luteinizing hormone-releasing hormone agonists (leuprolide or goserelin)\n* No concurrent androgen-receptor blocking agents (flutamide or bicalutamide)\n* No concurrent testosterone\n* No concurrent insulin\n* No concurrent finasteride\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* No prior orchiectomy\n\nOther:\n\n* No concurrent saw palmetto supplement'}, 'identificationModule': {'nctId': 'NCT00020995', 'briefTitle': 'Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Effects of a Low Fat Diet on Serum Factors and Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDR0000068737'}, 'secondaryIdInfos': [{'id': 'UCLA-0001030'}, {'id': 'NCI-G01-1973'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'therapeutic dietary intervention', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1738', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'William Aronson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}