Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-02-02 @ 10:10 PM
Study NCT ID:
NCT00716157
Status:
COMPLETED
Last Update Posted:
2014-12-05
First Post:
2008-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2008-07-14', 'studyFirstSubmitQcDate': '2008-07-15', 'lastUpdatePostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess incidence and patterns of nausea and vomiting in patients undergoing concurrent chemotherapy and radiation', 'timeFrame': 'week of treatment'}], 'secondaryOutcomes': [{'measure': "Assess the impact of nausea and vomiting on the patients' daily functioning", 'timeFrame': 'week of treatment'}, {'measure': 'Study the incidence of mucositis and esophagitis', 'timeFrame': 'week of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer of the Head and Neck', 'Cancer of the Lung', 'Cancer of the Esophagus', 'Gastro-esophageal Junction Cancer']}, 'descriptionModule': {'briefSummary': 'Questionnaire study to observe the incidence and pattern or nausea and vomiting in patients receiving combined chemotherapy and radiation. 83% of patients experience radiation therapy-induced vomiting; significant nausea and vomiting could develop with concurrent chemotherapy despite standard anti-nauseous medication prophylaxis.', 'detailedDescription': 'Questionnaires will be answered daily on a weekly basis during period of radiation and chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'University practice patients with aerodigestive malignancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Concurrent radiation and chemotherapy treatment\n* Aerodigestive malignancy\n\nExclusion Criteria:\n\n* Other causes of vomiting (i.e.gastrointestinal obstruction...)'}, 'identificationModule': {'nctId': 'NCT00716157', 'briefTitle': 'Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'A Prospective Study to Evaluate the Incidence and Patterns of Nausea and Vomiting in Patients Receiving Combined Chemotherapy and Radiation', 'orgStudyIdInfo': {'id': '04C.466'}, 'secondaryIdInfos': [{'id': '2004-16', 'type': 'OTHER', 'domain': 'CCRRC'}, {'id': '1002004024', 'type': 'OTHER_GRANT', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation', 'description': 'Adult patients receiving both radiation therapy and chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Rita Axelrod, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}