Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-28 @ 3:25 PM
Study NCT ID:
NCT00082732
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2004-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2006-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2004-05-14', 'studyFirstSubmitQcDate': '2004-05-18', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02-27', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage I prostate cancer', 'stage II prostate cancer', 'adenocarcinoma of the prostate'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center official website'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: A low-fat, high-fiber diet that includes soy protein may prevent disease progression in patients with hormone-refractory prostate cancer. Nutrition counseling may help motivate patients to follow this diet.\n\nPURPOSE: Randomized phase I trial to study the effectiveness of behavior-based dietary interventions, such as receiving nutrition counseling, in helping patients who have hormone-refractory prostate cancer follow a low-fat, high-fiber, soy-supplemented diet.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine whether a behavior-based dietary intervention can motivate patients with hormone-refractory prostate cancer to adopt and maintain a dietary pattern that includes \\< 20% of energy from fat, \\> 25 g of fiber, and 80 g of soy protein powder.\n* Compare bioavailable levels of testosterone in patients treated with a behavior-based dietary intervention vs observation only.\n* Determine whether this dietary intervention decreases or stabilizes a rising serum prostate-specific antigen level in these patients.\n* Determine whether this dietary intervention improves disease-specific survival, mediated by reduced bioavailable levels of testosterone, in these patients.\n* Determine the impact of a positive intervention outcome on androgen receptors in patients treated with this dietary intervention.\n\nOUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\nAll patients receive nutritional counseling on a healthy diet. Patients also keep a food diary during study participation.\n\n* Arm I (dietary intervention): Patients receive dietary intervention comprising nutritional counseling on a low-fat, high-fiber, soy supplemented diet and behavior-based activities, such as goal-setting, contracting, and stimulus control, once weekly for 6 weeks, every 3 weeks for 33 weeks, and then at weeks 44, 48, and 52. Treatment continues in the absence of disease progression or unacceptable toxicity.\n* Arm II (observation): Patients undergo observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks.\n\nPROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate\n\n * No small cell component\n* No histologically confirmed and/or demonstrable metastatic or locally recurrent disease by bone scan, chest x-ray, computed tomography (CT) scan, or transrectal ultrasound\n\n * No clinical symptoms within the past 90 days\n* Documented biochemical failure after radical prostatectomy\n\n * Prostate-specific antigen must have initially nadired to an undetectable level (\\< 0.1 ng/mL) after prostatectomy AND is currently rising (0.3-40.0 ng/mL)\n* Serum testosterone \\> 100 ng/dL\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Any age\n\nPerformance status\n\n* Zubrod 0-1\n\nLife expectancy\n\n* At least 1 year\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nOther\n\n* No known allergic reactions to milk or soy products\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* More than 1 year since prior chemotherapy\n\nEndocrine therapy\n\n* More than 1 year since prior hormonal therapy\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00082732', 'briefTitle': 'Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDR0000355833'}, 'secondaryIdInfos': [{'id': 'MDA-DM-98054'}, {'id': 'DM98-054', 'type': 'OTHER', 'domain': 'UT MD Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I: Dietary Intervention', 'description': 'Nutritional counseling on a low-fat, high-fiber, soy supplemented diet and behavior-based activities, such as goal-setting, contracting, and stimulus control, once weekly for 6 weeks, every 3 weeks for 33 weeks, and then at weeks 44, 48, and 52.', 'interventionNames': ['Behavioral: behavioral dietary intervention', 'Dietary Supplement: dietary intervention', 'Procedure: therapeutic dietary intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Arm II: Observation', 'description': 'Observation every 6 weeks for 36 weeks and then every 8 weeks for 18 weeks.'}], 'interventions': [{'name': 'behavioral dietary intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Arm I: Dietary Intervention']}, {'name': 'dietary intervention', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Arm I: Dietary Intervention']}, {'name': 'therapeutic dietary intervention', 'type': 'PROCEDURE', 'armGroupLabels': ['Arm I: Dietary Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Richard J. Babaian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}