Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-03 @ 6:47 PM
Study NCT ID:
NCT01867294
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2012-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D013473', 'term': 'Sunscreening Agents'}, {'id': 'D006854', 'term': 'Hydrocortisone'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011837', 'term': 'Radiation-Protective Agents'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D003879', 'term': 'Dermatologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D003358', 'term': 'Cosmetics'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jatoi.aminah@mayo.edu', 'phone': '507.284.1623', 'title': 'Aminah Jatoi, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed after one 4 week cycle, and after one 4-week observation prior for a maximum of up to 8 weeks.', 'description': 'Adverse events were assessed after one 4 week cycle, and after one 4-week observation prior for a maximum of up to 8 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Study I: Spironolactone', 'description': '.Patients apply spironolactone topically to face BID for 4 weeks.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hepatobiliary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Gastrointestinal stoma necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Intraoperative hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'INR increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Study I: Spironolactone', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.'}, {'id': 'OG001', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.'}, {'id': 'OG002', 'title': 'Study II: Spironolactone', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.'}, {'id': 'OG003', 'title': 'Study II: Modified Therapy', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 8 weeks', 'description': 'Adverse events were collected at the end of one 4-week cycle and one 4-week observation period according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a grade 2+ adverse event attributed to spironolactone is reported here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that began study treatment were included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Study I: Spironolactone', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.'}, {'id': 'OG001', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.'}, {'id': 'OG002', 'title': 'Study II: Spironolactone', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.'}, {'id': 'OG003', 'title': 'Study II: Modified Therapy', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 4 weeks', 'description': 'Adverse events were collected at the end of each 4-week cycle according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a truncal/extremity adverse event is reported here. The treatment will be considered feasible if at least 50% of patients in the spironolactone arm develop a truncal/extremity rash of any grade at the end of 4 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that began protocol treatment are included in this endpoint.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Study I: Spironolactone', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.'}, {'id': 'OG001', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.'}, {'id': 'OG002', 'title': 'Study II: Spironolactone', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.'}, {'id': 'OG003', 'title': 'Study II: Modified Therapy', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 4 weeks', 'description': 'The number of patients able to complete the 4-week study intervention and the 4-week observation period are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that began Study I treatment were included in this endpoint.'}, {'type': 'PRIMARY', 'title': 'Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Study I: Spironolactone', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.'}, {'id': 'OG001', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.'}, {'id': 'OG002', 'title': 'Study II: Spironolactone', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.'}, {'id': 'OG003', 'title': 'Study II: Modified Therapy', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.'}], 'timeFrame': 'At 4 weeks', 'description': 'The primary analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 4. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 4 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study II was not conducted.'}, {'type': 'SECONDARY', 'title': 'Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Study I: Spironolactone', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.'}, {'id': 'OG001', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.'}, {'id': 'OG002', 'title': 'Study II: Spironolactone', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.'}, {'id': 'OG003', 'title': 'Study II: Modified Therapy', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 4 weeks', 'description': 'Patients will be dichotomously categorized as a success if no rash is reported and a failure if rash exists at the end of 4 weeks. The number of patients that successfully completed 4 weeks of treatment and reported no rash on the Brief Pictorial Rash Incidence Questionnaire are reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that began study treatment are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Efficacy of the Modified Preemptive Therapy Regimen, Calculated and Analyzed Analogously to the Efficacy of the Spironolactone (Study II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Study I: Spironolactone', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.'}, {'id': 'OG001', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.'}, {'id': 'OG002', 'title': 'Study II: Spironolactone', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.'}, {'id': 'OG003', 'title': 'Study II: Modified Therapy', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.'}], 'timeFrame': 'At 4 weeks', 'description': 'All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study II was not conducted.'}, {'type': 'SECONDARY', 'title': 'Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Study I: Spironolactone', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.'}, {'id': 'OG001', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.'}, {'id': 'OG002', 'title': 'Study II: Spironolactone', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.'}, {'id': 'OG003', 'title': 'Study II: Modified Therapy', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.'}], 'timeFrame': 'At 8 weeks', 'description': 'This analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 8. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 8 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study II was not conducted.'}, {'type': 'SECONDARY', 'title': 'Incidence of Healthcare Provider Reported Adverse Events (Study II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Study I: Spironolactone', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.'}, {'id': 'OG001', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.'}, {'id': 'OG002', 'title': 'Study II: Spironolactone', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.'}, {'id': 'OG003', 'title': 'Study II: Modified Therapy', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.'}], 'timeFrame': 'At 8 weeks', 'description': 'All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study II was not conducted.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes as Measured by the Change From Baseline in the SKINDEX-16 Total Score (Study II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Study I: Spironolactone', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.'}, {'id': 'OG001', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.'}, {'id': 'OG002', 'title': 'Study II: Spironolactone', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.'}, {'id': 'OG003', 'title': 'Study II: Modified Therapy', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.'}], 'timeFrame': 'At 4 weeks', 'description': 'Total scores from the SKINDEX-16 will be compared from baseline to week 4. Comparisons between treatment arms will be made by t-tests.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study II was not conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study I: Spironolactone', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.'}, {'id': 'FG001', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.'}, {'id': 'FG002', 'title': 'Study II: Spironolactone', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.'}, {'id': 'FG003', 'title': 'Study II: Modified Therapy', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study II was never opened due to the accrual rate in Study I.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Study I: Spironolactone', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.'}, {'id': 'BG001', 'title': 'Study I: Placebo', 'description': 'Patients apply placebo topically to face BID for 4 weeks.'}, {'id': 'BG002', 'title': 'Study II: Spironolactone', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.'}, {'id': 'BG003', 'title': 'Study II: Modified Therapy', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'groupId': 'BG000', 'lowerLimit': '55.0', 'upperLimit': '77.0'}, {'value': '60.6', 'groupId': 'BG001', 'lowerLimit': '39.0', 'upperLimit': '82.0'}, {'value': '62.6', 'groupId': 'BG004', 'lowerLimit': '39', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All patients that were treated and eligible for endpoint analysis were include in baseline characteristics. One patient from Study I: Spironolactone and one from Study I: Placebo withdrew from study participation prior to receiving any study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2014-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2012-08-27', 'resultsFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2013-05-29', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-06', 'studyFirstPostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)', 'timeFrame': 'At 8 weeks', 'description': 'Adverse events were collected at the end of one 4-week cycle and one 4-week observation period according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a grade 2+ adverse event attributed to spironolactone is reported here.'}, {'measure': 'Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)', 'timeFrame': 'At 4 weeks', 'description': 'Adverse events were collected at the end of each 4-week cycle according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a truncal/extremity adverse event is reported here. The treatment will be considered feasible if at least 50% of patients in the spironolactone arm develop a truncal/extremity rash of any grade at the end of 4 weeks.'}, {'measure': 'Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I)', 'timeFrame': 'At 4 weeks', 'description': 'The number of patients able to complete the 4-week study intervention and the 4-week observation period are reported.'}, {'measure': 'Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II)', 'timeFrame': 'At 4 weeks', 'description': 'The primary analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 4. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 4 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I)', 'timeFrame': 'At 4 weeks', 'description': 'Patients will be dichotomously categorized as a success if no rash is reported and a failure if rash exists at the end of 4 weeks. The number of patients that successfully completed 4 weeks of treatment and reported no rash on the Brief Pictorial Rash Incidence Questionnaire are reported.'}, {'measure': 'Efficacy of the Modified Preemptive Therapy Regimen, Calculated and Analyzed Analogously to the Efficacy of the Spironolactone (Study II)', 'timeFrame': 'At 4 weeks', 'description': 'All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.'}, {'measure': 'Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II)', 'timeFrame': 'At 8 weeks', 'description': 'This analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 8. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 8 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.'}, {'measure': 'Incidence of Healthcare Provider Reported Adverse Events (Study II)', 'timeFrame': 'At 8 weeks', 'description': 'All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.'}, {'measure': 'Patient Reported Outcomes as Measured by the Change From Baseline in the SKINDEX-16 Total Score (Study II)', 'timeFrame': 'At 4 weeks', 'description': 'Total scores from the SKINDEX-16 will be compared from baseline to week 4. Comparisons between treatment arms will be made by t-tests.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignant Neoplasm', 'Dermatologic Complication']}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine feasibility of the administration of topical spironolactone versus placebo in this patient population. (Study I) II. To further explore the efficacy of the topical spironolactone to prevent/attenuate rash from EGFR inhibitors. (Study II)\n\nSECONDARY OBJECTIVES:\n\nI. To explore efficacy of the spironolactone versus placebo. (Study I) II. To describe the efficacy of a Modified Preemptive Therapy Regimen intervention. (Study II) III. To explore the adverse event profile of spironolactone and the Modified Preemptive Therapy Regimen intervention. (Study II) IV. To explore patient reported outcomes of patients using spironolactone and a Modified Preemptive Therapy Regimen intervention. (Study II) V. To explore long term (8 week) effect of the 4 week treatment of spironolactone and a Modified Preemptive Therapy Regimen intervention on EFGR induced rash. (Study II)\n\nOUTLINE:\n\nSTUDY I: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients apply spironolactone topically to face twice daily (BID) for 4 weeks.\n\nARM II: Patients apply placebo topically to face BID for 4 weeks.\n\nSTUDY II: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients apply spironolactone topically to face and body BID for 4 weeks\n\nARM II: Patients undergo modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically before going outside, hydrocortisone topically once daily (QD), and doxycycline orally (PO) BID for 4 weeks.\n\nAfter completion of study, patients are followed up for 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled to start panitumumab or cetuximab; patients must not have been on the EGFR agent prior to randomization\n* Ability to reliably apply topical spironolactone/placebo twice a day to the face\n* Ability to complete questionnaire(s) by themselves or with assistance\n* For study 2 only, patients must be willing to avoid sun exposure for one month from registration\n* Creatinine =\\< 1.5 x upper limit of normal (UNL)\n* For Study 2 only, ability to apply topical creams to the entire face and body\n\nExclusion Criteria:\n\n* Prior allergic reaction or severe intolerance to spironolactone\n* Any rash at the time of randomization\n* Cutaneous metastases\n* Any other disorder that may predispose to hyperkalemia in the opinion of the treating oncologist\n* Use of topical corticosteroids at the time of study or their anticipated use in the next 8 weeks; (it is acknowledged that patients may be starting these agents pre-emptively as part of this protocol)\n* For study 2 only, previous intolerance of sunscreen or any of the other components of the Modified Preemptive Therapy Regimen (a moisturizer or oral doxycycline)'}, 'identificationModule': {'nctId': 'NCT01867294', 'briefTitle': 'Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab', 'nctIdAliases': ['NCT02257086'], 'organization': {'class': 'OTHER', 'fullName': 'Academic and Community Cancer Research United'}, 'officialTitle': 'A Two-Part, Phase II Randomized Trial to Explore Topical Spironolactone to Prevent/Attenuate Rash From Epidermal Growth Factor Receptor Inhibitors (Panitumumab and Cetuximab) in Advanced Cancer Patients', 'orgStudyIdInfo': {'id': 'RC09C8'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01275', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'RC09C8', 'type': 'OTHER', 'domain': 'Academic and Community Cancer Research United'}, {'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (Study I)', 'description': 'Patients apply spironolactone topically to face BID for 4 weeks.', 'interventionNames': ['Other: Questionnaire Administration', 'Drug: Spironolactone']}, {'type': 'EXPERIMENTAL', 'label': 'Arm I (Study II)', 'description': 'Patients apply spironolactone topically to face and body BID for 4 weeks.', 'interventionNames': ['Other: Questionnaire Administration', 'Drug: Spironolactone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II (Study I)', 'description': 'Patients apply placebo topically to face BID for 4 weeks.', 'interventionNames': ['Other: Placebo', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (Study II)', 'description': 'Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.', 'interventionNames': ['Drug: Doxycycline', 'Procedure: Management of Therapy Complications', 'Other: Questionnaire Administration', 'Drug: Sunscreen', 'Drug: Therapeutic Hydrocortisone']}], 'interventions': [{'name': 'Doxycycline', 'type': 'DRUG', 'otherNames': ['Doxycycline Monohydrate'], 'description': 'Given PO', 'armGroupLabels': ['Arm II (Study II)']}, {'name': 'Management of Therapy Complications', 'type': 'PROCEDURE', 'description': 'Moisturizer given topically', 'armGroupLabels': ['Arm II (Study II)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['placebo therapy', 'PLCB', 'sham therapy'], 'description': 'Given topically', 'armGroupLabels': ['Arm II (Study I)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (Study I)', 'Arm I (Study II)', 'Arm II (Study I)', 'Arm II (Study II)']}, {'name': 'Spironolactone', 'type': 'DRUG', 'otherNames': ['17-Hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic Acid, gamma Lactone, Acetate', 'Aldactone', 'SC 9420', 'SPL'], 'description': 'Given topically', 'armGroupLabels': ['Arm I (Study I)', 'Arm I (Study II)']}, {'name': 'Sunscreen', 'type': 'DRUG', 'otherNames': ['Sunblock'], 'description': 'Given topically', 'armGroupLabels': ['Arm II (Study II)']}, {'name': 'Therapeutic Hydrocortisone', 'type': 'DRUG', 'otherNames': ['Aeroseb-HC', 'Barseb HC', 'Barseb-HC', 'Cetacort', 'Cort-Dome', 'Cortef', 'Cortenema', 'Cortifan', 'Cortisol', 'Cortispray', 'Cortril', 'Dermacort', 'Domolene', 'Eldecort', 'Hautosone', 'Heb-Cort', 'hydrocortisone', 'Hydrocortone', 'Hytone', 'Komed-HC', 'Nutracort', 'Proctocort', 'Rectoid'], 'description': 'Given topically', 'armGroupLabels': ['Arm II (Study II)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa-Wide Oncology Research Coalition NCORP', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '56303', 'city': 'Saint Cloud', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Coborn Cancer Center at Saint Cloud Hospital', 'geoPoint': {'lat': 45.5608, 'lon': -94.16249}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'Aminah Jatoi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academic and Community Cancer Research United'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academic and Community Cancer Research United', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}