Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-01 @ 12:21 AM
Study NCT ID:
NCT00594620
Status:
TERMINATED
Last Update Posted:
2022-02-14
First Post:
2008-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jholzbeierlein@kumc.edu', 'phone': '913-945-8239', 'title': 'Jeffrey Holzbeierlein, MD, FACS', 'organization': 'The University of Kansas'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination due to low accrual. Insufficient number of participants for accurate analysis. No data collected.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Flav-ein Capsules', 'description': 'Subjects receive supplement\n\nFlav-ein capsules: Soy/isoflavone supplementation', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects will receive placebo\n\nPlacebo: Placebo', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flav-ein Capsules', 'description': 'Subjects receive supplement\n\nFlav-ein capsules: Soy/isoflavone supplementation'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive placebo\n\nPlacebo: Placebo'}], 'timeFrame': '16 Weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'The trial was stopped early due to failure to accrue Not enough subjects were enrolled with enough follow up to have data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1/ Soy Supplementation', 'description': 'Subjects receive supplement\n\nFlav-ein capsules: Soy/isoflavone supplementation'}, {'id': 'FG001', 'title': 'Arm 2/ Placebo', 'description': 'Subjects will receive placebo\n\nPlacebo: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Study was terminated early due to low accrual. Study was blinded and no data was collected', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Study was terminated early due to low accrual. Study was blinded and no data was collected', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Study was terminated early due to low accrual. Study was blinded and no data was collected'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1/ Soy Supplementation', 'description': 'Subjects receive supplement\n\nFlav-ein capsules: Soy/isoflavone supplementation'}, {'id': 'BG001', 'title': 'Arm 2/ Placebo', 'description': 'Subjects will receive placebo\n\nPlacebo: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}]}], 'populationDescription': 'This trial was stopped early due to low enrollment. There was not a sufficient number of participants to accurately analyze the data. Randomization was not completed prior to termination. Data for population analysis not collected.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Terminated due to poor accrual and without sufficient patients or data to report on any outcomes.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2008-01-03', 'resultsFirstSubmitDate': '2020-06-26', 'studyFirstSubmitQcDate': '2008-01-14', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-20', 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens', 'timeFrame': '16 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer', 'detailedDescription': 'Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven adenocarcinoma of prostate with treatment of prostate cancer (radical prostatectomy, radiation therapy, etc.)\n* had biochemical/clinical relapse and started on antiandrogens\n* have documented history of hot flashes\n\nExclusion Criteria:\n\n* History of MI, DVT, CVA\n* peanut allergy\n* untreated hypothyroidism\n* must be off other medical treatment for hot flashes for 2 weeks before enrollment in this study'}, 'identificationModule': {'nctId': 'NCT00594620', 'briefTitle': 'Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy', 'orgStudyIdInfo': {'id': '9639'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Subjects receive supplement', 'interventionNames': ['Dietary Supplement: Flav-ein capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Subjects will receive placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Flav-ein capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Soy/isoflavone supplementation', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Jeffrey M. Holzbeierlein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}