Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-01-01 @ 10:33 AM
Study NCT ID:
NCT07000032
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-31
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Swallowing Function of Oral Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'For investigating the specific nutrition gene'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2025-05-23', 'studyFirstSubmitQcDate': '2025-05-23', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bolus presence time', 'timeFrame': 'one year after surgery', 'description': 'The opening of hypopharynx'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral cancer surgery', 'swallowing', 'nutrition'], 'conditions': ['The Swallowing Changes']}, 'descriptionModule': {'briefSummary': 'This study enrolled patients who underwent oral cancer resection. Swallowing function, muscle status, and nutritional status were assessed before treatment, one month after treatment, and between three months to one year post-treatment.', 'detailedDescription': 'Dysphagia is a common and debilitating symptom among patients who undergo oral cancer resection with reconstruction followed by adjuvant radiotherapy. During the course of the disease, approximately 20% to 98% of patients experience swallowing difficulties. This is primarily caused by tumor destruction, postoperative sequelae from surgical resection, and the adverse effects of radiotherapy and chemotherapy. The use of chemotherapy or radiotherapy-particularly when combined-increases the incidence of complications such as oropharyngeal mucositis, odynophagia, dysgeusia, xerostomia, nausea, vomiting, and fatigue. These complications may lead to dehydration and significant weight loss, which in turn negatively impact nutritional status, functional ability, and quality of life.\n\nThis study enrolled patients who underwent oral cancer surgery. Swallowing function, muscle status, and nutritional status were assessed before treatment, one month after treatment, and between three months to one year post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing oral cancer surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing oral cancer\n\nExclusion Criteria:\n\n* patients unable to unable to cooperate with the examination'}, 'identificationModule': {'nctId': 'NCT07000032', 'briefTitle': 'The Swallowing Function of Oral Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'A Longitudinal Study on Dysphagia and Associated Nutritional Complications Following Oral Cancer Surgery', 'orgStudyIdInfo': {'id': '202501062RINA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients undergoing oral cancer surgery', 'description': 'patients undergoing oral cancer surgery', 'interventionNames': ['Other: No Intervention: Observational Cohort']}], 'interventions': [{'name': 'No Intervention: Observational Cohort', 'type': 'OTHER', 'description': 'This is an observational cohort', 'armGroupLabels': ['patients undergoing oral cancer surgery']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chih-Jun Lai, MD, PhD', 'role': 'CONTACT', 'email': 'littlecherrytw@gmail.com', 'phone': '+886-972652086'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to ethical issue'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending anesthesiologist', 'investigatorFullName': 'National Taiwan University Clinical Trial Center', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}