Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT00746694
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2008-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010292', 'term': 'Paresthesia'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Study data may be used in general publications or at conferences. Authorship will be attributed to those responsible for preparing the report and/or those who had a relevant part in designing the study. Whenever publication rules allow, all investigators will be listed individually.\n\nInvestigators may publish their data individually. In this case investigators will notify the study sponsor, including the communication/manuscript to be published, at least 30 days before submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Caelyx', 'description': 'Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.', 'otherNumAtRisk': 154, 'otherNumAffected': 122, 'seriousNumAtRisk': 154, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 51, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 68, 'numAffected': 68}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 61, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 44, 'numAffected': 44}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caelyx', 'description': 'Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.'}], 'classes': [{'title': 'Oral Dexamethosone', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Pyridoxine', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Topical Corticosteroids', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Topical Dimethyl Sulfoxide', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Intravenous Dexamethasone', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Prostaglandins', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Avoid Excessive Heat/Water', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Keep Skin Hydrated', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Avoid Sweating and Physical Activity', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Avoid Tight-Fitting Clothing', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Local Cooling of Hands and Feet', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will do a single visit, but cases will be collected during a period of 12 months.', 'description': 'Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE.\n\nParticipants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caelyx', 'description': 'Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.'}], 'classes': [{'title': 'Curative Treatment', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Prophylaxis', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Curative & Prophylactic Treatment', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Participants will do a single visit, but cases will be collected during a period of 12 months.', 'description': 'The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caelyx', 'description': 'Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Caelyx', 'description': 'Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.4', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '154', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-26', 'studyFirstSubmitDate': '2008-09-03', 'resultsFirstSubmitDate': '2010-12-21', 'studyFirstSubmitQcDate': '2008-09-03', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-21', 'studyFirstPostDateStruct': {'date': '2008-09-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)', 'timeFrame': 'Participants will do a single visit, but cases will be collected during a period of 12 months.', 'description': 'Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE.\n\nParticipants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it.'}, {'measure': 'Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE', 'timeFrame': 'Participants will do a single visit, but cases will be collected during a period of 12 months.', 'description': 'The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ovarian Neoplasms', 'Breast Neoplasms', 'Paresthesia']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to study the management of PPE in participants with metastatic ovarian or breast cancer treated with Caelyx, and determine the frequency of use of pharmacological treatment (preventive or therapeutic) for PPE and compliance of educational recommendations for PPE.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with metastatic ovarian or breast cancer, to be recruited from the Oncology Departments of 16 centers for a period of 12 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18 years of age or older.\n* Participants with metastatic breast or ovarian cancer who are receiving treatment with pegylated liposomal doxorubicin.\n* Participants who have given their written consent.\n\nExclusion Criteria:\n\n* Participants who are currently participating in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT00746694', 'briefTitle': 'A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Epidemiological Study to Assess the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Pegylated Liposomal Doxorubicin', 'orgStudyIdInfo': {'id': 'P05020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Caelyx', 'description': 'Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment and according to data sheet approved indications.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}