Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-28 @ 1:00 PM
Study NCT ID:
NCT04823468
Status:
COMPLETED
Last Update Posted:
2025-06-10
First Post:
2021-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of weight loss > 5%', 'timeFrame': 'From time of randomization to the date of radiotherapy ends, up to 7 weeks', 'description': 'The percentage of patients whose body weight decreased more than 5% over baseline, body weight (in kilograms) are measured at baseline and weekly during the course of radiotherapy'}], 'secondaryOutcomes': [{'measure': 'PG-SGA Score', 'timeFrame': 'From time of randomization to the date of radiotherapy ends, up to 7 weeks', 'description': 'The scores assessed by Patient-Generated Subjective Nutrition Assessment (PG-SGA) at baseline and weekly during the course of radiotherapy'}, {'measure': 'Incidence of participants with grade ≥3 oral mucositis', 'timeFrame': 'During the course of radiotherapy, up to 7 weeks', 'description': 'Incidence of grade 3-4 oral mucositis assessed by CTCAE v5.0, evaluated weekly during radiotherapy'}, {'measure': 'Days of radiotherapy interruption', 'timeFrame': 'During the course of radiotherapy, up to 7 weeks', 'description': 'The number of days that radiotherapy was interrupted due to treatment-related toxicity'}, {'measure': 'Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 v3.0 (EORTC QLQ-C30 v3.0)', 'timeFrame': 'From time of randomization to the date of radiotherapy ends, up to 7 weeks', 'description': 'The standard scores assessed by the EORTC QLQ-C30 v3.0 at baseline and the end of radiotherapy.'}, {'measure': 'Increment Cost-Utility Ratio (ICUR）', 'timeFrame': 'During the course of chemoradiotherapy, up to 7 weeks', 'description': 'The Increment cost-utility ratio is used to assess the economics of ONS, which is calculated as incremental cost divided by incremental utility.'}, {'measure': 'Score of EQ-5D-5L questionnaire', 'timeFrame': 'During the course of chemoradiotherapy, up to 7 weeks', 'description': 'The standard scores assessed by the EuroQol- 5 dimension-5 level (EQ-5D-5L ) questionnaire. Collect this questionnaire only in the responsible center.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal Carcinoma', 'Nutritional Support', 'Chemoradiotherapy', 'Dietary Supplements', 'Body Weight', 'Cost-Effectiveness Analysis'], 'conditions': ['Nasopharyngeal Carcinoma', 'Nutritional Support']}, 'descriptionModule': {'briefSummary': 'Concurrent chemoradiotherapy(CCRT) is the principal treatment for nasopharyngeal carcinoma(NPC). Studies have shown that malnutrition is very common in patients with NPC after chemoradiotherapy. Malnutrition can lead to weight loss, treatment interruption, prolonged stay in hospital, increased treatment costs, reduced tolerance to anti-tumor therapy, reduced quality of life and shortened survival time. Nutritional intervention can improve the nutritional status, reduce treatment-related toxicity and improve the survival of patients with NPC.\n\nThe first choice of nutritional intervention is oral nutritional supplements(ONS). Some retrospective studies with small samples have found that early nutritional intervention can reduce weight loss and severe oral mucositis in patients with NPC, compared with late nutritional intervention. Therefore, the investigators proposed the hypothesis that ONS from the beginning of radiotherapy can reduce the nutritional impairment, treatment-related toxicity and treatment costs of patients with NPC, and improve their quality of life. The aim of this multicenter randomized controlled clinical trial is to evaluate the efficacy and cost utility of ONS from the beginning to the end of radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly histologic diagnosis of nasopharyngeal carcinoma;\n* All genders, range from 18-70 years old;\n* Clinical stage II-IVa according to the 8th edition of the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) staging system;\n* Patient-Generated Subjective Nutrition Assessment (PG-SGA) score ≤8;\n* Main organ functions test should be satisfied the following conditions: (1) Absolute neutrophil count (ANC) ≥1.5×10\\^9/L; (2) Platelet (PLT) ≥80×10\\^9/L; (3) Hemoglobin (Hb) ≥90 g/L; (4) Bilirubin \\< 1.5 times the upper limit of normal value (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\< 2.5 times the upper limit of normal value; (5) Creatinine \\< 1.5 times the upper limit of normal value or creatinine clearance rate \\>60 ml/min.\n\nExclusion Criteria:\n\n* Patients whose energy intake is less than 60% of the target energy requirement for 3 days or more;\n* Have or are suffering from other malignant tumors;\n* Refuse concurrent chemoradiotherapy;\n* With diabetics, galactosemia, or sever metabolic diseases or endocrine diseases;\n* Cannot take oral or enteral nutrition, including intestinal obstruction, severe short bowel syndrome or high output fistula, or with severe digestive system diseases;\n* Known allergic reaction to any component of Abbott®Ensure, or severe allergic constitution;\n* Pregnant or lactating women;\n* With previous or ongoing clinical trials;\n* Refuse to sign inform consent form.'}, 'identificationModule': {'nctId': 'NCT04823468', 'briefTitle': 'Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': 'Effect of Oral Nutritional Supplements From the Beginning of Radiotherapy on Body Weight Loss of Patients With Nasopharyngeal Carcinoma and Its Cost-Utility Analysis: A Prospective Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FYYY-FLK-202001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'In addition to conventional dietary instruction and individualized nutritional counselling, patients were given additional ONS (Abbott®Ensure of 55.8 g tid) from the beginning to the end of radiotherapy.', 'interventionNames': ['Dietary Supplement: Abbott®Ensure', 'Radiation: Intensity Modulated Radiation Therapy', 'Drug: cisplatin']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.', 'interventionNames': ['Radiation: Intensity Modulated Radiation Therapy', 'Drug: cisplatin']}], 'interventions': [{'name': 'Abbott®Ensure', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy', 'armGroupLabels': ['Experimental group']}, {'name': 'Intensity Modulated Radiation Therapy', 'type': 'RADIATION', 'description': 'The prescribed dose was 68-76 Gy to Planning target volume of the primary tumor (PTVnx), 66-70 Gy to Planning target volume of the cervical lymph node (PTVnd), 60-64 Gy to planning target volume 1 (PTV1), and 50-54 Gy to planning target volume 2 (PTV2) in 30-33 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'cisplatin', 'type': 'DRUG', 'description': '80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '350014', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '350025', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': '900th hospital of the joint logistics team, PLA', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '353000', 'city': 'Nanping', 'state': 'Fujian', 'country': 'China', 'facility': 'The Nanping First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.645, 'lon': 118.17361}}, {'zip': '362000', 'city': 'Quanzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Quanzhou First Hospital Affiliated to Fujian Medical University', 'geoPoint': {'lat': 24.91389, 'lon': 118.58583}}, {'zip': '362000', 'city': 'Quanzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 24.91389, 'lon': 118.58583}}, {'zip': '361003', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'The First Affiliated Hospital of Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '361004', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Zhongshan Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '363000', 'city': 'Zhangzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Zhangzhou Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 24.51333, 'lon': 117.65556}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '330029', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Jiangxi Provincial Cancer Hospital', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}], 'overallOfficials': [{'name': 'Jinsheng Hong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Fujian Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinsheng Hong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, {'name': 'The Second Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'The Nanping First Affiliated Hospital of Fujian Medical University', 'class': 'UNKNOWN'}, {'name': 'Quanzhou First Hospital', 'class': 'OTHER'}, {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, {'name': 'Zhangzhou Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'Hunan Cancer Hospital', 'class': 'OTHER'}, {'name': 'Jiangxi Provincial Cancer Hospital', 'class': 'OTHER'}, {'name': '900 Hospital of Joint Logistics Support Force of PLA', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, {'name': 'Zhongshan Hospital Xiamen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jinsheng Hong', 'investigatorAffiliation': 'First Affiliated Hospital of Fujian Medical University'}}}}