Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-02 @ 4:47 AM
Study NCT ID:
NCT00354432
Status:
TERMINATED
Last Update Posted:
2021-09-28
First Post:
2006-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Soy Protein/Effexor Hormone Therapy for Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D030262', 'term': 'Soybean Proteins'}, {'id': 'D007529', 'term': 'Isoflavones'}, {'id': 'D000069470', 'term': 'Venlafaxine Hydrochloride'}, {'id': 'D002364', 'term': 'Caseins'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D010940', 'term': 'Plant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014674', 'term': 'Plant Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D045730', 'term': 'Soy Foods'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D010750', 'term': 'Phosphoproteins'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dcase@wakehealth.edu', 'phone': '(336) 716-5425', 'title': 'Dr. Doug Case', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study was stopped early by the DSMB due to a lack of effect.'}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I - Placebo', 'description': 'Patients receive oral placebo pill and oral placebo powder once daily.', 'otherNumAtRisk': 30, 'otherNumAffected': 28, 'seriousNumAtRisk': 30, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Arm II - Soy', 'description': 'Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.', 'otherNumAtRisk': 27, 'otherNumAffected': 23, 'seriousNumAtRisk': 27, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Arm III - Venlafaxine', 'description': 'Patients receive oral Venlafaxine pill and placebo powder once daily.', 'otherNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Arm IV - Soy + Venlafaxine', 'description': 'Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.', 'otherNumAtRisk': 28, 'otherNumAffected': 27, 'seriousNumAtRisk': 28, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Allergic Reaction/hypersensitivity including drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 12, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 23, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 29, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constitutional Symptioms - Nightmares', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea - without colostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Distension/Bloating, Abdominal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 28, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 16, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 22, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ejaculatory Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 58, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 36, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 39, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 36, 'numAffected': 12}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Erectile Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 62, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 42, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 37, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 32, 'numAffected': 12}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 47, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 36, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 35, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 36, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 22, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 21, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 17, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 27, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 45, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 20, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 26, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 26, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood Alteration - Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood Alteration - Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 15, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurology - Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neuropathy - Sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 38, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 43, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 32, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 19, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Extremity - Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Petechiae/purpura - hemorrhage/bleeding into skin or mucosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal/Genitourinary - Other (Specify, __)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sweating - Diaphoresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 61, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 64, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 63, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 74, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary Frequency/Urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Erectile Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 13, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 13, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection - Rectum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration - Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mood alteration- Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Obstruction - Ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - chest NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain - joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vascular - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hot Flash Symptom Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I - Placebo', 'description': 'Patients receive oral placebo pill and oral placebo powder once daily.'}, {'id': 'OG001', 'title': 'Arm II - Soy', 'description': 'Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.'}, {'id': 'OG002', 'title': 'Arm III - Venlafaxine', 'description': 'Patients receive oral Venlafaxine pill and placebo powder once daily.'}, {'id': 'OG003', 'title': 'Arm IV - Soy + Venlafaxine', 'description': 'Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '77.2', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '68.9', 'spread': '12.1', 'groupId': 'OG002'}, {'value': '73.8', 'spread': '11.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.3455', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'The null hypothesis was that there was no difference in the hot flash severity score at 12 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'A mixed effects repeated measures analysis of variance was used with the baseline means constrained to be equal in the four groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100\\*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome.', 'unitOfMeasure': 'percent of baseline score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were analyzed in a repeated measures mixed model. This allowed inclusion of all study participants.'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I - Placebo', 'description': 'Patients receive oral placebo pill and oral placebo powder once daily.'}, {'id': 'OG001', 'title': 'Arm II - Soy', 'description': 'Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.'}, {'id': 'OG002', 'title': 'Arm III - Venlafaxine', 'description': 'Patients receive oral Venlafaxine pill and placebo powder once daily.'}, {'id': 'OG003', 'title': 'Arm IV - Soy + Venlafaxine', 'description': 'Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '115.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '121.5', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '114.3', 'spread': '2.7', 'groupId': 'OG002'}, {'value': '117.7', 'spread': '2.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2081', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.', 'groupDescription': 'Null hypothesis was that there was no difference in quality of life between the four groups at 12 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with baseline and 12 week quality of life data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I - Placebo', 'description': 'Patients receive oral placebo pill and oral placebo powder once daily.'}, {'id': 'FG001', 'title': 'Arm II - Soy', 'description': 'Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.'}, {'id': 'FG002', 'title': 'Arm III - Venlafaxine', 'description': 'Patients receive oral venlafaxine pill and oral placebo powder once daily.'}, {'id': 'FG003', 'title': 'Arm IV - Soy + Venlafaxin', 'description': 'Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Off/Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I - Placebo', 'description': 'Patients receive oral placebo pill and oral placebo powder once daily.'}, {'id': 'BG001', 'title': 'Arm II - Soy', 'description': 'Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.'}, {'id': 'BG002', 'title': 'Arm III - Venlafaxine', 'description': 'Patients receive oral venlafaxine pill and oral placebo powder once daily.'}, {'id': 'BG003', 'title': 'Arm IV - Soy + Venlafaxine', 'description': 'Patients receive oral venlafaxine pill and oral soy protein/isoflavones powder once daily.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '71.0', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '67.8', 'spread': '9.9', 'groupId': 'BG002'}, {'value': '67.5', 'spread': '9.1', 'groupId': 'BG003'}, {'value': '68.5', 'spread': '9.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'whyStopped': 'Stopped by the DSMB for lack of effect per interim stopping rule.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2010-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2006-07-19', 'resultsFirstSubmitDate': '2015-07-15', 'studyFirstSubmitQcDate': '2006-07-19', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-12', 'studyFirstPostDateStruct': {'date': '2006-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hot Flash Symptom Severity Score', 'timeFrame': '12 weeks', 'description': 'The primary objective of this randomized trial is to assess the effect of soy and Venlafaxine on the hot flash symptom severity score in men undergoing hormonal manipulation for treatment of prostate cancer. Hot flash severity will be quantitated using the symptom diary (as the sum of the number of hot flashes (any number greater than or equal to 0) times their severity (0=none, 1=mild, 2=moderate, 3=severe)). The primary end point is the 12 week hot flash score relative to the baseline value (i.e., 100\\*(12 week score)/baseline score). The range is 0 to infinity. Lower values represent a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '12 weeks', 'description': 'Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P). The FACT-P consists of four general subscales (functional, emotional, social, and physical) consisting of a total of 27 questions as well as a Prostate specific subscale consisting of 12 questions. Each question is answered on a 0 to 4 scale. The FACT-P score ranges from 0 to 156; higher scores denote better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recurrent prostate cancer', 'stage I prostate cancer', 'stage IIB prostate cancer', 'stage IIA prostate cancer', 'stage III prostate cancer', 'stage IV prostate cancer', 'hot flashes'], 'conditions': ['Hot Flashes', 'Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '24081940', 'type': 'DERIVED', 'citation': 'Vitolins MZ, Griffin L, Tomlinson WV, Vuky J, Adams PT, Moose D, Frizzell B, Lesser GJ, Naughton M, Radford JE Jr, Shaw EG. Randomized trial to assess the impact of venlafaxine and soy protein on hot flashes and quality of life in men with prostate cancer. J Clin Oncol. 2013 Nov 10;31(32):4092-8. doi: 10.1200/JCO.2012.48.1432. Epub 2013 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Soy protein/isoflavones and venlafaxine may help relieve hot flashes in patients receiving hormone therapy for prostate cancer. It is not yet known whether soy protein/isoflavones are more effective than venlafaxine when given together or with a placebo in treating hot flashes.\n\nPURPOSE: This randomized phase III trial is studying soy protein/isoflavones and venlafaxine to compare how well they work when given together or with a placebo in treating hot flashes in patients receiving hormone therapy for prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Assess the effect of soy protein/isoflavones and venlafaxine on the hot flash symptom severity score in patients undergoing hormonal manipulation for treatment of prostate cancer.\n\nSecondary\n\n* Assess the effect of soy protein/isoflavones and venlafaxine on quality of life of these patients.\n* Monitor and assess the participant drop out rate.\n\nOUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to severity of disease (metastatic vs nonmetastatic) and baseline severity of hot flashes. Patients are randomized to 1 of 4 treatment arms.\n\n* Arm I: Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.\n* Arm II: Patients receive oral venlafaxine and oral placebo powder once daily.\n* Arm III: Patients receive oral venlafaxine and oral soy protein/isoflavones powder once daily.\n* Arm IV: Patients receive oral placebo pill and oral placebo powder once daily. Treatment in all arms continues for 12 weeks in the absence of disease progression or unacceptable toxicity. After 12 weeks of treatment, patients in arms I and III receive a tapered dose of oral venlafaxine once daily for 1 week.\n\nPatients complete a vasomotor symptom diary once daily beginning 7 days before the initiation of study treatment and continuing until the completion of study treatment. Quality of life is assessed at baseline and at week 12.\n\nPROJECTED ACCRUAL: A total of 176 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologic documentation of prostate cancer, any stage Life expectancy of \\> nine months\n* Prior or current androgen deprivation for treatment or control of prostate cancer to include:\n* Bilateral Orchiectomy\n* LHRH agonist (with or without antiandrogen therapy) ie: leuprolide (Lupron), goserelin (Zoladex), bicalutamide (Casodex), flutamide (Eulexin), or similar agents\n* Chemotherapy\n* Radiation (Patients may undergo concurrent radiation therapy to the prostate, prostate + seminal vesicles, and/or pelvis). Seed implants are allowed\n* Participant report of hot flash frequency of an average of four or more per day, as defined by sweating, flushing, sensation of warmth, night sweats (Average of 28 per week)\n* Hot flashes must be moderate or severe (See appendix A for hot flash definitions)\n* Grade 2 (Moderate flashes) are warmer, produce obvious perspiration, and last 2 to 3 minutes\n* Grade 3 (Severe flashes) causes profuse perspiration, generate intense heat, last longer and interfere with ongoing activity\n* Age \\>21\n* No allergies to soy or dairy products\n* No current use of SSRIs, SNRI's, MAOIs, or Linezolide\n* No uncontrolled hypertension (160/90) or greater than Class I American Heart Association functional capacity\n* No history of mania, hypomania, bipolar disorder, or anorexia nervosa\n* No history of seizures\n* No history of hepatic dysfunction)\n* Must have a telephone\n* Signed protocol-specific Informed Consent\n* Participants consuming soy foods or soy based supplements must continue on a stable regimen during study participation\n* Patients should maintain same treatment and medications for prostate cancer throughout entire study.\n* No change in treatment for 2 weeks prior to registration.\n* Current use of medications and herbal supplements for hot flashes are allowed if on a stable regimen throughout the entire study. (Does not include anti-depressants)\n\nExclusion Criteria:\n\n* Anticipated changes in prostate cancer treatment plan (i.e., hormonal manipulation, changes in chemotherapy)\n* Concurrent antidepressant therapy\n* History of intolerance to venlafaxine\n* Recent (within 14 days) use of venlafaxine (Effexor XRTM), monoamine oxidase inhibitor, SSRI (selective serotonin reuptake inhibitor), or SNRI (selective norepinephrine reuptake inhibitor)\n* History of seizure disorder"}, 'identificationModule': {'nctId': 'NCT00354432', 'briefTitle': 'Soy Protein/Effexor Hormone Therapy for Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Randomized Study of Soy Protein and Effexor on Vasomotor Symptoms of Men With Prostate Cancer', 'orgStudyIdInfo': {'id': 'REBAcccwfu97405'}, 'secondaryIdInfos': [{'id': 'U10CA081851', 'link': 'https://reporter.nih.gov/quickSearch/U10CA081851', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I - Placebo', 'description': 'Patients receive oral placebo pill and oral placebo powder once daily.', 'interventionNames': ['Dietary Supplement: Placebo Powder', 'Drug: Placebo Pill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II - Soy', 'description': 'Patients receive oral placebo pill and oral soy protein/isoflavones powder once daily.', 'interventionNames': ['Dietary Supplement: oral soy protein/isoflavones powder', 'Drug: Placebo Pill']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III - Venlafaxine', 'description': 'Patients receive oral Venlafaxine pill and placebo powder once daily.', 'interventionNames': ['Drug: Venlafaxine', 'Dietary Supplement: Placebo Powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm IV - Soy + Venlafaxine', 'description': 'Patients receive oral Venlafaxine pill and soy protein/isoflavones powder once daily.', 'interventionNames': ['Dietary Supplement: oral soy protein/isoflavones powder', 'Drug: Venlafaxine']}], 'interventions': [{'name': 'oral soy protein/isoflavones powder', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Protein powder', 'Supplement powder soy and casein 20gm', 'Isoflavones', 'Isocaloric supplement', 'Casein protein'], 'description': 'Soy protein powder (20gm) orally 160 mg of total isoflavones isocaloric supplement of casein protein', 'armGroupLabels': ['Arm II - Soy', 'Arm IV - Soy + Venlafaxine']}, {'name': 'Venlafaxine', 'type': 'DRUG', 'otherNames': ['Effexor XR', 'placebo'], 'description': 'Patients receive oral venlafaxine 75mg.', 'armGroupLabels': ['Arm III - Venlafaxine', 'Arm IV - Soy + Venlafaxine']}, {'name': 'Placebo Powder', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Casein'], 'description': 'Placebo powder (20gm casein protein) orally 0 mg of total isoflavones', 'armGroupLabels': ['Arm I - Placebo', 'Arm III - Venlafaxine']}, {'name': 'Placebo Pill', 'type': 'DRUG', 'otherNames': ['Sugar Pill'], 'description': 'Patients receive oral placebo pill.', 'armGroupLabels': ['Arm I - Placebo', 'Arm II - Soy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'MBCCOP - JHS Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Central Illinois', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'CCOP - Northern Indiana CR Consortium', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'CCOP - Cedar Rapids Oncology Project', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'MBCCOP - LSU Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '71130-3932', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Feist-Weiller Cancer Center at Louisiana State University Health Sciences', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - 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