Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT00716560
Status:
TERMINATED
Last Update Posted:
2025-05-06
First Post:
2008-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009325', 'term': 'Nausea'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Administratively terminated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2008-07-14', 'studyFirstSubmitQcDate': '2008-07-14', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine incidence of nausea when receiving Dartmouth regimen chemotherapy for metastatic melanoma', 'timeFrame': 'Week of treatment'}], 'secondaryOutcomes': [{'measure': 'Assess the impact of systemic chemotherapy with Dartmouth regimen on quality of life of patients', 'timeFrame': 'week of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Melanoma', 'Nausea']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.KimmelCancerCenter.org', 'label': 'Kimmel Cancer Center at Thomas Jefferson University'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe the incidence of nausea with systemic chemotherapy that includes consecutive days (more than one day)of cisplatin medication.', 'detailedDescription': 'Questionnaires are completed on week of chemotherapy treatment referred to as Dartmouth regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'University practice patients with metastatic melanoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis metastatic melanoma\n* 18 years and older\n* undergoing chemotherapy with Dartmouth regimen\n* medically stable to receive chemotherapy per physical and clinical laboratory tests\n\nExclusion Criteria:\n\n* No medical conditions that interfere with assessment of nausea and vomiting during chemotherapy\n* No cognitive disorder that impairs symptom assessment\n* No other investigational agent\n* Inability to swallow medications for nausea and vomiting\n* No gastric outlet obstruction'}, 'identificationModule': {'nctId': 'NCT00716560', 'briefTitle': 'Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Nausea and Vomiting In Patients Receiving Consecutive Days of Cisplatin', 'orgStudyIdInfo': {'id': '05C.202'}, 'secondaryIdInfos': [{'id': '2004-101', 'type': 'OTHER', 'domain': 'CCRRC'}, {'id': '0402005015', 'type': 'OTHER_GRANT', 'domain': 'Merck & Co, Inc.'}, {'id': 'JT 1069', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Metastatic melanoma treatment with Dartmouth regimen'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Takami Sato, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Cancer Center at Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}