Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-05-30 @ 5:23 AM
Study NCT ID:
NCT04199832
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2019-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Compare the Effect of Different Nutritional Pathways on Improving Nutritional Status of Esophageal Cancer Patients Undergoing Chemoradiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck 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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2019-12-02', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Weight Change from baseline to the end of treatment', 'timeFrame': 'up to 1 month after the treatment', 'description': 'Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.'}], 'secondaryOutcomes': [{'measure': 'Blood biochemical examination', 'timeFrame': 'up to 1 month after the treatment', 'description': 'albumin,prealbumin,haemoglobin,et al, record the changes before and after the treatment.'}, {'measure': 'Scored Patient-Generated Subjective Global Assessment (PG-SGA)', 'timeFrame': 'up to 1 month after the treatment', 'description': 'Nutritional status evaluation table. score: 0-1 A: well-nourished; score：2-8 B: moderately malnourished; score：≥9 C: severely malnourished.'}, {'measure': 'EORTC QLQ-C30', 'timeFrame': 'up to 1 month after the treatment', 'description': 'Quality of life evaluation form. QLQ-C30 results were linearly transformed to scores 0 to 100. Higher scores represent worse symptoms in the symptom scales and better function in functional scales.'}, {'measure': 'Grade 3-5 toxicity', 'timeFrame': 'up to 1 month after the treatment', 'description': 'Grade 3-5 adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 andthe criteria of the Radiation Therapy Oncology Group ，such as esophagitis、pneumonitis 、hematologic toxicity and infection rate'}, {'measure': 'Completion rate of chemoradiotherapy', 'timeFrame': 'up to 1 month after the treatment', 'description': 'The proportion of people who complete all treatment as required'}, {'measure': 'Overall Survival', 'timeFrame': 'at least 2 years', 'description': 'overall survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma', 'Chemoradiotherapy', 'Enteral Nutrition']}, 'referencesModule': {'references': [{'pmid': '37150411', 'type': 'DERIVED', 'citation': 'Dong J, Dai Z, Cao F, Zhang W, Zhang T, Chen X, Chen Y, Zhao F, Li J, Du Q, Zhang K, Zeng Y, Li C, Wang Y, Li Y, Wang K, Pang Q. Effects of PEG in patients with esophageal squamous cell carcinoma during concurrent chemoradiotherapy: a prospective study. Gastrointest Endosc. 2023 Dec;98(6):901-910.e3. doi: 10.1016/j.gie.2023.04.2094. Epub 2023 May 5.'}]}, 'descriptionModule': {'briefSummary': 'This study prospectively recruited esophageal squamous-cell carcinoma patients who received nasogastric tube (NG), gastrostomy feeding and oral intake to compare the changes in nutritional status and quality of life during chemoradiation therapy (CRT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with esophageal squamous cell carcinoma who received concurrent chemoradiotherapy voluntarily chose different nutritional treatment paths according to the degree of dysphagia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically or cytologically proven esophageal squamous cell carcinoma\n* Karnofsky performance score(KPS) ≧70\n* Concurrent chemoradiotherapy\n* Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\< 2.5 times upper limit of normal,bilirubin normal\n* Creatinine normal OR creatinine clearance ≥ 60 mL/min\n* Patients have good compliance to treatment and follow-up of acceptance\n* the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications\n\nExclusion Criteria:\n\n* Patients with severely bowel function impaired or can not tolerate enteral nutrition\n* Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted\n* Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction\n* Patients who have distant metastasis\n* The primary tumor or lymph node already received surgical treatment efuse or incapable to sign the informed consent form of participating this trial'}, 'identificationModule': {'nctId': 'NCT04199832', 'briefTitle': 'To Compare the Effect of Different Nutritional Pathways on Improving Nutritional Status of Esophageal Cancer Patients Undergoing Chemoradiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'Nutritional Status and Complications in Patients Undergoing Chemoradiotherapy for Esophageal Squamous Cell Carcinomas: a Comparison of Nasogastric Tube, Percutaneous Endoscopic Gastrostomy Tube and Oral Supplement', 'orgStudyIdInfo': {'id': '20190920'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nasogastric tube', 'description': 'The patient had difficulty swallowing before chemoradiotherapy and placed a nasogastric tube.', 'interventionNames': ['Dietary Supplement: Dietary guidance']}, {'label': 'gastrostomy feeding', 'description': 'Patients with dysphagia before chemoradiotherapy began to voluntarily choose gastrostomy feeding.', 'interventionNames': ['Dietary Supplement: Dietary guidance']}, {'label': 'Oral intake', 'description': 'Patients with normal swallowing or not receiving tube feeding.', 'interventionNames': ['Dietary Supplement: Dietary guidance']}], 'interventions': [{'name': 'Dietary guidance', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding.', 'armGroupLabels': ['Nasogastric tube', 'Oral intake', 'gastrostomy feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Department of Radiation Oncology, Tianjin Medical University cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Qingsong Pang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Radiation Oncology,Tianjin Medical University cancer Institute and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}