Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-28 @ 9:10 PM
Study NCT ID:
NCT01205503
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2010-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D000084202', 'term': 'Chemotherapy-Related Cognitive Impairment'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015080', 'term': 'Mesna'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emilydressler@uky.edu', 'phone': '859 323-3076', 'title': 'Emily Dressler, PhD', 'organization': 'Markey Cancer Center Biostatistics Shared Resource Facility'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We did not measure any cognitive outcomes. We did not measure levels of anti-inflammatory cytokines, which could play a role in pathophysiology of Chemotherapy induced cognitive impairment (CICI). Small sample size, needs future trials to confirm.'}}, 'adverseEventsModule': {'timeFrame': 'All participants were followed clinically during first 2 cycles of therapy, for up to 24 weeks, and adverse events were assessed and classified using the Common Terminology Criteria for Adverse Events version 4.', 'eventGroups': [{'id': 'EG000', 'title': 'Mesna', 'description': 'Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during cycle assigned by randomization\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes', 'otherNumAtRisk': 32, 'otherNumAffected': 29, 'seriousNumAtRisk': 32, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Saline', 'description': 'Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during cycle assigned by randomization\n\nInfused over 15 minutes', 'otherNumAtRisk': 32, 'otherNumAffected': 30, 'seriousNumAtRisk': 32, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bullous Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema Limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophageal Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flank Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle weakness upper limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'MRSA positive infection in toe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 1 Saline; Cycle 2 Mesna', 'description': 'Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes\n\nSaline: Saline (used as a placebo) infused over the same time as mesna intervention'}, {'id': 'OG001', 'title': 'Cycle 1 Mesna; Cycle 2 Saline', 'description': 'Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes\n\nSaline: Saline (used as a placebo) infused over the same time as mesna intervention'}], 'classes': [{'title': 'Cycle 1 Pre', 'categories': [{'measurements': [{'value': '3.55', 'groupId': 'OG000', 'lowerLimit': '1.96', 'upperLimit': '6.42'}, {'value': '3.68', 'groupId': 'OG001', 'lowerLimit': '1.98', 'upperLimit': '6.81'}]}]}, {'title': 'Cycle 1 Post', 'categories': [{'measurements': [{'value': '2.95', 'groupId': 'OG000', 'lowerLimit': '1.54', 'upperLimit': '5.64'}, {'value': '3.18', 'groupId': 'OG001', 'lowerLimit': '1.79', 'upperLimit': '5.64'}]}]}, {'title': 'Cycle 2 Pre', 'categories': [{'measurements': [{'value': '2.26', 'groupId': 'OG000', 'lowerLimit': '1.37', 'upperLimit': '3.73'}, {'value': '1.67', 'groupId': 'OG001', 'lowerLimit': '1.35', 'upperLimit': '2.07'}]}]}, {'title': 'Cycle 2 Post', 'categories': [{'measurements': [{'value': '1.78', 'groupId': 'OG000', 'lowerLimit': '1.05', 'upperLimit': '3.03'}, {'value': '1.29', 'groupId': 'OG001', 'lowerLimit': '1.01', 'upperLimit': '1.65'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'This is for the interaction between baseline tnf-alpha levels and treatment received (mesna vs saline).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model was adjusted for baseline biochemical measures, time of measurement, treatment (mesna or saline), chemo type, and first-order interactions.', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to and 3 hours post doxorubicin and between cycles 1 and 2', 'description': 'Continuous Measure of TNF-alpha at the 4 time points outlined in the protocol for each group.', 'unitOfMeasure': 'log(pg/ml)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 1 Saline; Cycle 2 Mesna', 'description': 'Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes\n\nSaline: Saline (used as a placebo) infused over the same time as mesna intervention'}, {'id': 'OG001', 'title': 'Cycle 1 Mesna; Cycle 2 Saline', 'description': 'Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes\n\nSaline: Saline (used as a placebo) infused over the same time as mesna intervention'}], 'classes': [{'title': 'Cycle 1 Post', 'categories': [{'measurements': [{'value': '108.82', 'groupId': 'OG000', 'lowerLimit': '88.20', 'upperLimit': '134.26'}, {'value': '73.54', 'groupId': 'OG001', 'lowerLimit': '48.09', 'upperLimit': '112.42'}]}]}, {'title': 'Cycle 2 Pre', 'categories': [{'measurements': [{'value': '100.52', 'groupId': 'OG000', 'lowerLimit': '79.52', 'upperLimit': '127.07'}, {'value': '97.00', 'groupId': 'OG001', 'lowerLimit': '79.32', 'upperLimit': '118.61'}]}]}, {'title': 'Cycle 2 Post', 'categories': [{'measurements': [{'value': '87.91', 'groupId': 'OG000', 'lowerLimit': '62.70', 'upperLimit': '96.99'}, {'value': '75.71', 'groupId': 'OG001', 'lowerLimit': '49.81', 'upperLimit': '115.08'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to and 3 hours post doxorubicin and between cycles 1 and 2', 'description': "Continuous Measure of percent changes from baseline of Protein Carbonyl at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.", 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 1 Saline; Cycle 2 Mesna', 'description': 'Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes\n\nSaline: Saline (used as a placebo) infused over the same time as mesna intervention'}, {'id': 'OG001', 'title': 'Cycle 1 Mesna; Cycle 2 Saline', 'description': 'Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes\n\nSaline: Saline (used as a placebo) infused over the same time as mesna intervention'}], 'classes': [{'title': 'Cycle 1 Post', 'categories': [{'measurements': [{'value': '98.95', 'groupId': 'OG000', 'lowerLimit': '89.06', 'upperLimit': '109.94'}, {'value': '102.63', 'groupId': 'OG001', 'lowerLimit': '94.74', 'upperLimit': '111.17'}]}]}, {'title': 'Cycle 2 Pre', 'categories': [{'measurements': [{'value': '100.52', 'groupId': 'OG000', 'lowerLimit': '79.52', 'upperLimit': '127.07'}, {'value': '97.00', 'groupId': 'OG001', 'lowerLimit': '79.32', 'upperLimit': '118.61'}]}]}, {'title': 'Cycle 2 Post', 'categories': [{'measurements': [{'value': '87.91', 'groupId': 'OG000', 'lowerLimit': '62.70', 'upperLimit': '123.26'}, {'value': '75.71', 'groupId': 'OG001', 'lowerLimit': '49.81', 'upperLimit': '115.08'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to and 3 hours post doxorubicin and between cycles 1 and 2', 'description': "Continuous Measure of the percent change from baseline of Plasma HNE at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.", 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 1 Saline; Cycle 2 Mesna', 'description': 'Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes\n\nSaline: Saline (used as a placebo) infused over the same time as mesna intervention'}, {'id': 'OG001', 'title': 'Cycle 1 Mesna; Cycle 2 Saline', 'description': 'Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes\n\nSaline: Saline (used as a placebo) infused over the same time as mesna intervention'}], 'classes': [{'title': 'Cycle 1 Pre', 'categories': [{'measurements': [{'value': '0.015', 'groupId': 'OG000', 'lowerLimit': '0.011', 'upperLimit': '0.021'}, {'value': '0.017', 'groupId': 'OG001', 'lowerLimit': '0.013', 'upperLimit': '0.021'}]}]}, {'title': 'Cycle 1 Post', 'categories': [{'measurements': [{'value': '0.014', 'groupId': 'OG000', 'lowerLimit': '0.010', 'upperLimit': '0.019'}, {'value': '0.012', 'groupId': 'OG001', 'lowerLimit': '0.010', 'upperLimit': '0.015'}]}]}, {'title': 'Cycle 2 Pre', 'categories': [{'measurements': [{'value': '0.020', 'groupId': 'OG000', 'lowerLimit': '0.014', 'upperLimit': '0.029'}, {'value': '0.016', 'groupId': 'OG001', 'lowerLimit': '0.012', 'upperLimit': '0.021'}]}]}, {'title': 'Cycle 2 Post', 'categories': [{'measurements': [{'value': '0.021', 'groupId': 'OG000', 'lowerLimit': '0.014', 'upperLimit': '0.030'}, {'value': '0.019', 'groupId': 'OG001', 'lowerLimit': '0.014', 'upperLimit': '0.026'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to and 3 hours post doxorubicin and between cycles 1 and 2', 'description': 'Continuous Measure of troponin at the 4 time points outlined in the protocol for each group.', 'unitOfMeasure': 'ng/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 1 Saline; Cycle 2 Mesna', 'description': 'Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes\n\nSaline: Saline (used as a placebo) infused over the same time as mesna intervention'}, {'id': 'OG001', 'title': 'Cycle 1 Mesna; Cycle 2 Saline', 'description': 'Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes\n\nSaline: Saline (used as a placebo) infused over the same time as mesna intervention'}], 'classes': [{'title': 'Cycle 1 Pre', 'categories': [{'measurements': [{'value': '46.36', 'groupId': 'OG000', 'lowerLimit': '32.23', 'upperLimit': '66.69'}, {'value': '49.24', 'groupId': 'OG001', 'lowerLimit': '33.00', 'upperLimit': '73.48'}]}]}, {'title': 'Cycle 1 Post', 'categories': [{'measurements': [{'value': '50.73', 'groupId': 'OG000', 'lowerLimit': '34.16', 'upperLimit': '75.35'}, {'value': '47.17', 'groupId': 'OG001', 'lowerLimit': '31.30', 'upperLimit': '71.07'}]}]}, {'title': 'Cycle 2 Pre', 'categories': [{'measurements': [{'value': '45.85', 'groupId': 'OG000', 'lowerLimit': '36.19', 'upperLimit': '58.08'}, {'value': '46.30', 'groupId': 'OG001', 'lowerLimit': '31.15', 'upperLimit': '68.82'}]}]}, {'title': 'Cycle 2 Post', 'categories': [{'measurements': [{'value': '54.33', 'groupId': 'OG000', 'lowerLimit': '41.72', 'upperLimit': '70.73'}, {'value': '46.66', 'groupId': 'OG001', 'lowerLimit': '32.03', 'upperLimit': '67.97'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'prior to and 3 hours post doxorubicin and between cycles 1 and 2', 'description': 'Continuous Measure of BNP at the 4 time points outlined in protocol for each of the groups. This is a 32-amino acid polypeptide secreted by heart ventricles in response to excessive stretching of cardiomyocytes.', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cycle 1 Saline; Cycle 2 Mesna', 'description': 'Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes'}, {'id': 'FG001', 'title': 'Cycle 1 Mesna; Cycle 2 Saline', 'description': 'Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes'}], 'periods': [{'title': 'First Intervention (1st Cycle)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (2nd Cycle)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited at the University of Kentucky Markey Cancer Center in Lexington, Kentucky, USA between October 2010 and May 2012.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cycle 1 Saline; Cycle 2 Mesna', 'description': 'Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes'}, {'id': 'BG001', 'title': 'Cycle 1 Mesna; Cycle 2 Saline', 'description': 'Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle\n\nMesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.81', 'spread': '11.70', 'groupId': 'BG000'}, {'value': '51.75', 'spread': '15.51', 'groupId': 'BG001'}, {'value': '54.78', 'spread': '1.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Treatment Type', 'classes': [{'title': 'Doxorubicin and cyclophosphamide (AC)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'AC, vincristine, and prednisone (CHOP)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Doxorubicin, cyclophosphamide and docetaxel (TAC)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'title': '0- Fully Active', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': '1- Restricted', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cancer Diagnosis', 'classes': [{'title': 'Breast', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Lymphoma', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Surface Area (BSA)', 'classes': [{'categories': [{'measurements': [{'value': '2.01', 'spread': '0.23', 'groupId': 'BG000'}, {'value': '1.93', 'spread': '0.26', 'groupId': 'BG001'}, {'value': '1.97', 'spread': '0.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'log TNF Alpha', 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '1.11', 'groupId': 'BG000'}, {'value': '1.30', 'spread': '1.16', 'groupId': 'BG001'}, {'value': '1.28', 'spread': '1.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log(pg/ml)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'log TNF receptor 1', 'classes': [{'categories': [{'measurements': [{'value': '7.29', 'spread': '0.44', 'groupId': 'BG000'}, {'value': '7.04', 'spread': '0.46', 'groupId': 'BG001'}, {'value': '7.17', 'spread': '0.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log(pg/ml)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Log interleukin (IL)-18', 'classes': [{'categories': [{'measurements': [{'value': '6.06', 'spread': '0.93', 'groupId': 'BG000'}, {'value': '6.16', 'spread': '0.76', 'groupId': 'BG001'}, {'value': '6.11', 'spread': '0.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log(pg/ml)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Log Protein Carbonyl (PC)', 'classes': [{'categories': [{'measurements': [{'value': '4.39', 'spread': '0.34', 'groupId': 'BG000'}, {'value': '4.33', 'spread': '0.38', 'groupId': 'BG001'}, {'value': '4.36', 'spread': '0.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log(nmol/mg protein)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Log Plasma 4-hydroxynonenal (HNE)', 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.22', 'groupId': 'BG000'}, {'value': '-0.28', 'spread': '0.20', 'groupId': 'BG001'}, {'value': '-0.29', 'spread': '0.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This baseline measurement is standardized to the control on the plate and then log transformed. The resulting ratio of plate assay value relative to control can be \\< 1 resulting in a negative log value.', 'unitOfMeasure': 'log(pmol/mg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Log 3-nitrotyrosine (3NT)', 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.26', 'groupId': 'BG000'}, {'value': '-0.05', 'spread': '0.16', 'groupId': 'BG001'}, {'value': '-0.08', 'spread': '0.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This baseline measurement is standardized to the control on the plate and then log transformed. The resulting ratio of plate assay value relative to control can be \\< 1 resulting in a negative log value.', 'unitOfMeasure': 'log(ng/mg protein)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Log TNF Receptor 2', 'classes': [{'categories': [{'measurements': [{'value': '8.31', 'spread': '0.68', 'groupId': 'BG000'}, {'value': '8.15', 'spread': '0.74', 'groupId': 'BG001'}, {'value': '8.23', 'spread': '0.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log(pg/ml)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All subjects that received treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2010-09-17', 'resultsFirstSubmitDate': '2015-09-18', 'studyFirstSubmitQcDate': '2010-09-17', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-27', 'studyFirstPostDateStruct': {'date': '2010-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy', 'timeFrame': 'prior to and 3 hours post doxorubicin and between cycles 1 and 2', 'description': 'Continuous Measure of TNF-alpha at the 4 time points outlined in the protocol for each group.'}], 'secondaryOutcomes': [{'measure': 'Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy', 'timeFrame': 'prior to and 3 hours post doxorubicin and between cycles 1 and 2', 'description': "Continuous Measure of percent changes from baseline of Protein Carbonyl at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure."}, {'measure': 'Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy', 'timeFrame': 'prior to and 3 hours post doxorubicin and between cycles 1 and 2', 'description': "Continuous Measure of the percent change from baseline of Plasma HNE at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure."}, {'measure': 'Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy', 'timeFrame': 'prior to and 3 hours post doxorubicin and between cycles 1 and 2', 'description': 'Continuous Measure of troponin at the 4 time points outlined in the protocol for each group.'}, {'measure': 'B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy', 'timeFrame': 'prior to and 3 hours post doxorubicin and between cycles 1 and 2', 'description': 'Continuous Measure of BNP at the 4 time points outlined in protocol for each of the groups. This is a 32-amino acid polypeptide secreted by heart ventricles in response to excessive stretching of cardiomyocytes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chemobrain', 'Oxidative Stress', 'Mesna'], 'conditions': ['Breast Cancer', "Non-Hodgkin's Lymphoma"]}, 'referencesModule': {'references': [{'pmid': '25909710', 'type': 'RESULT', 'citation': 'Hayslip J, Dressler EV, Weiss H, Taylor TJ, Chambers M, Noel T, Miriyala S, Keeney JT, Ren X, Sultana R, Vore M, Butterfield DA, St Clair D, Moscow JA. Plasma TNF-alpha and Soluble TNF Receptor Levels after Doxorubicin with or without Co-Administration of Mesna-A Randomized, Cross-Over Clinical Study. PLoS One. 2015 Apr 24;10(4):e0124988. doi: 10.1371/journal.pone.0124988. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the drug mesna is able to block a series of chemical changes that occur in the blood of patients who receive the chemotherapy medicine doxorubicin. The researchers believe these blood chemical changes may the cause of "cloudy thinking" or "chemobrain" that are reported by some patients receiving chemotherapy.', 'detailedDescription': 'Patients with lymphoma and breast cancer receiving chemotherapy regimens that include anthracycline drugs, such as doxorubicin, are at risk for developing cognitive and cardiac impairment. This potential cognitive impairment is refered to as "chemobrain" by some patients. We have demonstrated in mice that the drug mesna, which is used to prevent other complications of other chemotherapy drugs, prevents certain types of doxorubicin-induced damage of blood proteins. Blocking doxorubicin\'s damage of these blood proteins has blunted or prevented the subsequent markers of neurologic and cardiac injury in mice. This clinical trial will determine if mesna prevents doxorubicin-induced damage of blood proteins in cancer patients, and may establish if blood protein injury is the first step in anthracycline-induced cognitive and cardiac dysfunction and if using the drug mesna can blunt or prevent these changes in blood markers of injury for patients with cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must have histologically or cytologically confirmed breast cancer or non-hodgkin lymphoma and independent of protocol eligibility be determined to require one of the chemotherapy regimens listed below\n\nParticipants must require as standard-of-care treatment a chemotherapy regimen that includes one of the following combinations:\n\n* doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2;\n* doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2, and docetaxel 75 mg/m2;\n* doxorubicin 50 mg/m2, cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 (capped at 2 mg dose), and prednisone 100 mg +/- rituximab 375 mg/m2\n\nAge \\>18 years.Because these treatment regimens are rarely used in pediatric oncology, children are excluded from this study but will be eligible for future pediatric phase 2 trials.\n\nLife expectancy of greater than 6 months.\n\nZubrod performance score 2 or better.\n\nPatients must have normal organ and marrow function as defined below:\n\n* leukocytes \\>3,000/microliter (mcL) (unless due to cancer in marrow)\n* absolute neutrophil count \\>1,500/mcL (unless due to cancer in marrow)\n* platelets \\>100,000/mcL (unless due to cancer in marrow)\n* total bilirubin \\<1.5 X normal institutional limits\n* Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT)/Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) \\<2.5 X institutional upper limit of normal\n* creatinine within normal institutional limits OR\n* creatinine clearance \\>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal\n* left ventricular function ≥ 50 % ejection fraction\n\nBecause the standard of care chemotherapy agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nAbility to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nPatients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n\nPatients may not be receiving any other investigational agents\n\nPatients with known brain metastases should be excluded from this clinical trial because progressive neurologic dysfunction would confound the evaluation of neuro-cognitive outcomes.\n\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to mesna or other agents used in the study (ie. sulfur containing drugs including "sulfa antibiotics" and celecoxib).\n\nPatients requiring ongoing pharmacologic treatment of dementia are excluded.\n\nUncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n\nPregnant women are excluded from this study because the chemotherapy agents have known teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued if the mother is treated with chemotherapy.\n\nHIV-positivity is NOT a specific exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT01205503', 'briefTitle': 'Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Randomized, Blinded Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and TNF-α Release', 'orgStudyIdInfo': {'id': '10-0431-F1V'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cycle 1 Saline; Cycle 2 Mesna', 'description': 'Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) with following Cyclophosphamide 6 hours post doxorubicin during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion with following Cyclophosphamide 6 hours post doxorubicin during 2nd cycle', 'interventionNames': ['Drug: Mesna', 'Drug: Saline', 'Drug: Doxorubicin', 'Drug: Cyclophosphamide']}, {'type': 'OTHER', 'label': 'Cycle 1 Mesna; Cycle 2 Saline', 'description': 'Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion with following Cyclophosphamide 6 hours post doxorubicin during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) with following Cyclophosphamide 6 hours post doxorubicin during 2nd cycle', 'interventionNames': ['Drug: Mesna', 'Drug: Saline', 'Drug: Doxorubicin', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'Mesna', 'type': 'DRUG', 'otherNames': ['Mesnex'], 'description': 'Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes', 'armGroupLabels': ['Cycle 1 Mesna; Cycle 2 Saline', 'Cycle 1 Saline; Cycle 2 Mesna']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Saline (used as a placebo) infused over the same time as mesna intervention', 'armGroupLabels': ['Cycle 1 Mesna; Cycle 2 Saline', 'Cycle 1 Saline; Cycle 2 Mesna']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'otherNames': ['Adriamycin'], 'description': '60mg/m2 given IV over 15 minutes after receiving mesna or saline. Can allow for premedications of Ondansetron 8 mg orally, dexamethasone 12 mg orally, Aprepitant 125 mg orally.', 'armGroupLabels': ['Cycle 1 Mesna; Cycle 2 Saline', 'Cycle 1 Saline; Cycle 2 Mesna']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Endoxan', 'Cytoxan', 'Neosar', 'Procytox', 'Revimmune', 'Cycloblastin'], 'description': '600 mg/m2 IV over 30 minutes. Start 6 hours after doxorubicin started.', 'armGroupLabels': ['Cycle 1 Mesna; Cycle 2 Saline', 'Cycle 1 Saline; Cycle 2 Mesna']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Markey Cancer Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Mara Chambers, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Markey Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The de-identified data is already available as part of the published article supplement. PubMed Identification (ID) # 25909710'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mara Chambers', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mara Chambers', 'investigatorAffiliation': 'University of Kentucky'}}}}