Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2026-04-15 @ 9:05 PM
Study NCT ID:
NCT05126095
Status:
UNKNOWN
Last Update Posted:
2021-12-02
First Post:
2021-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Skeletal Muscle Mass Using CBCT in Patients With H&N Cancer Undergoing Chemoradiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-21', 'studyFirstSubmitDate': '2021-11-07', 'studyFirstSubmitQcDate': '2021-11-07', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The treatment-related severe adverse events', 'timeFrame': '7 weeks', 'description': 'The association between Loss of SMM and treatment-related severe adverse events including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission in HNC patients during radiotherapy.'}], 'secondaryOutcomes': [{'measure': 'The weight loss percentage', 'timeFrame': '7 weeks', 'description': 'The association between percentage Loss of SMM and weight loss percetage in HNC patients during radiotherapy'}, {'measure': 'Scored Patient-Generated Subjective Global Assessment (PG-SGA)', 'timeFrame': '7 weeks', 'description': 'The association between Loss of SMM and PG-SGA in HNC patients during radiotherapy. The PG-SGA scores typically range from 0-35, with a higher score reflecting a greater risk of malnutrition.'}, {'measure': 'the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)', 'timeFrame': '7 weeks', 'description': 'The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy'}, {'measure': 'the European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Cancer Module (EORTC QLQ-H&N35)', 'timeFrame': '7 weeks', 'description': 'The association between Loss of SMM and Quality Of Life in HNC patients during radiotherapy'}, {'measure': 'Duration ofParenteral nutrition', 'timeFrame': '7 weeks', 'description': 'The association between Loss of SMM and duration of parenteral nutrition in HNC patients during radiotherapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cone-beam Computerized tomography', 'Skeletal Muscle Mass', 'Body weight', 'Malnutrition'], 'conditions': ['Head and Neck Cancer', 'Radiotherapy; Adverse Effect']}, 'descriptionModule': {'briefSummary': 'Chemoradiotherapy is the standard treatment for unresectable locally advanced head and neck cancer (HNC). However, malnutrition is present in 44-88% HNC patients during chemoradiotherapy, which leads to loss of skeletal muscle mass (SMM) and poor clinical outcomes. Timely assessment of SMM and early intervention of malnutrition are particularly important for HNC patients undergoing radiotherapy. However, body composition and skeletal muscle loss are not accurately reflected by the current assessment tools of malnutrition, which only measure body mass index and body weight loss.\n\nCone-beam CT (CBCT), a variation of traditional CT, is widely performed to ensure the appropriate position of the patients during radiotherapy. The previous study showed that measuring skeletal muscle areas and its changes using CBCT during radiotherapy is feasible. The hypothesis of this study is loss of SMM is associated with severe adverse effects in HNC patients during radiotherapy compared with body weight loss.', 'detailedDescription': 'This is a prospective observational phase II study. Patients with locally advanced HNC scheduled to receive radical radiotherapy are prospectively enrolled in this study. CBCT and body weight are obtained before radiotherapy and once a week during radiotherapy. Severe adverse effects including grade 3-4 mucositis, dermatitis, haematological toxicity, interruption of radiotherapy, delayed chemotherapy, and unplanned admission are recorded during radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with locally advanced HNC scheduled to receive radical radiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed HNC including Oral Cavity, Oropharyngeal, Nasopharynx, Hypopharyngeal, and Laryngeal Cancers\n* Clinical stage II-IVa according to the American Joint Committee of Cancer (the seventh edition)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n\nExclusion Criteria:\n\n* Previous head and neck radiotherapy\n* Previous cervical lymph node dissection\n* Active infections\n* Palliative treatment'}, 'identificationModule': {'nctId': 'NCT05126095', 'acronym': 'MELINOE', 'briefTitle': 'Monitoring Skeletal Muscle Mass Using CBCT in Patients With H&N Cancer Undergoing Chemoradiotherapy', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Monitoring Skeletal Muscle Mass Using Cone-Beam Computed Tomography in Patients With Head and Neck Cancer Undergoing Chemoradiotherapy: Single-center Prospective Study', 'orgStudyIdInfo': {'id': 'KY-Q-2021-213'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trial cohort', 'description': 'CBCT: before radiotherapy and once a week during radiotherapy\n\nBody weight: before radiotherapy and once a week during radiotherapy\n\nThe Patient-Generated Subjective Global Assessment (PG-SGA): before radiotherapy, 1st week, 3rd week and the last week during radiotherapy.', 'interventionNames': ['Radiation: Radical radiotherapy']}], 'interventions': [{'name': 'Radical radiotherapy', 'type': 'RADIATION', 'description': 'Intensity-modulated radiation therapy (IMRT)', 'armGroupLabels': ['Trial cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'YI PAN', 'role': 'CONTACT', 'email': 'panyiff01@163.com'}], 'facility': 'YI PAN', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yi Pan, Prof.', 'role': 'CONTACT', 'email': 'panyiff01@163.com', 'phone': '+862083827812', 'phoneExt': '50150'}], 'overallOfficials': [{'name': 'YI PAN, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'YI PAN', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}