Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2026-01-01 @ 6:10 AM
Study NCT ID:
NCT06829095
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2023-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Nutrition Counseling and Nutritional Status of Esophageal Cancer and HNSCC Patients Undergoing CCRT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2023-11-10', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI in kg/m^2-W1', 'timeFrame': 'baseline', 'description': "Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'BMI in kg/m^2-W2', 'timeFrame': '2nd week', 'description': "Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'BMI in kg/m^2-W3', 'timeFrame': '3rd week', 'description': "Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'BMI in kg/m^2-W4', 'timeFrame': '4th week', 'description': "Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'BMI in kg/m^2-W5', 'timeFrame': '5th week', 'description': "Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'BMI in kg/m^2-W6', 'timeFrame': '6th week', 'description': "Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'BMI in kg/m^2-W12', 'timeFrame': '12th week', 'description': "Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'BMI in kg/m^2-W18', 'timeFrame': '18th week', 'description': "Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'BMI in kg/m^2-W30', 'timeFrame': '30th week', 'description': "Document of participant's BMI and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'hand grip in kg-W1', 'timeFrame': 'baseline', 'description': "Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'hand grip in kg-W2', 'timeFrame': '2nd week', 'description': "Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'hand grip in kg-W3', 'timeFrame': '3rd week', 'description': "Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'hand grip in kg-W4', 'timeFrame': '4th week', 'description': "Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'hand grip in kg-W5', 'timeFrame': '5th week', 'description': "Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'hand grip in kg-W6', 'timeFrame': '6th week', 'description': "Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'hand grip in kg-W12', 'timeFrame': '12th week', 'description': "Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'hand grip in kg-W18', 'timeFrame': '18th week', 'description': "Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'hand grip in kg-W30', 'timeFrame': '30th week', 'description': "Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'body fat in kg-W1', 'timeFrame': 'baseline', 'description': "Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'body fat in kg-W2', 'timeFrame': '2nd week', 'description': "Document of participant's hand grip and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'body fat in kg-W3', 'timeFrame': '3rd week', 'description': "Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'body fat in kg-W4', 'timeFrame': '4th week', 'description': "Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'body fat in kg-W5', 'timeFrame': '5th week', 'description': "Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'body fat in kg-W6', 'timeFrame': '6th week', 'description': "Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'body fat in kg-W12', 'timeFrame': '12th week', 'description': "Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'body fat in kg-W18', 'timeFrame': '18th week', 'description': "Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'body fat in kg-W30', 'timeFrame': '30th week', 'description': "Document of participant's body fat and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'muscle weight in kg-W1', 'timeFrame': 'baseline', 'description': "Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'muscle weight in kg-W2', 'timeFrame': '2nd week', 'description': "Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'muscle weight in kg-W3', 'timeFrame': '3rd week', 'description': "Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'muscle weight in kg-W4', 'timeFrame': '4th week', 'description': "Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'muscle weight in kg-W5', 'timeFrame': '5th week', 'description': "Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'muscle weight in kg-W6', 'timeFrame': '6th week', 'description': "Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'muscle weight in kg-W12', 'timeFrame': '12th week', 'description': "Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'muscle weight in kg-W18', 'timeFrame': '18th week', 'description': "Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'muscle weight in kg-W30', 'timeFrame': '30th week', 'description': "Document of participant's muscle weight and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'CTC cell number counting in number-W1', 'timeFrame': 'baseline', 'description': "Document of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'CTC cell number counting in number-W6', 'timeFrame': '6th week', 'description': "Document of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status"}, {'measure': 'CTC cell number counting in number-W18', 'timeFrame': '18th week', 'description': "Document of participant's CTC cell number counting and evaluating the effectiveness of nutritionist health education nutritional status"}], 'secondaryOutcomes': [{'measure': 'Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W1', 'timeFrame': 'baseline', 'description': 'nutrition consultation and do the SGA questionnaire(the minimum value is 1 and the maximum value is 36. The higher scores mean a worse outcome) for recoding and improving the nutritional status of participants.'}, {'measure': 'Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W3', 'timeFrame': '3th week', 'description': 'nutrition consultation and do the SGA questionnaire(the minimum value is 1 and the maximum value is 36. The higher scores mean a worse outcome) for recoding and improving the nutritional status of participants.'}, {'measure': 'Abridged Patient-Generated Subjective Global Assessment, aPG-SGA Questionnaire W6', 'timeFrame': '6th week', 'description': 'nutrition consultation and do the SGA questionnaire(the minimum value is 1 and the maximum value is 36. The higher scores mean a worse outcome) for recoding and improving the nutritional status of participants.'}, {'measure': 'aPG SGA Questionnaire W18', 'timeFrame': '18th week', 'description': 'nutrition consultation and do the SGA questionnaire(the minimum value is 1 and the maximum value is 36. The higher scores mean a worse outcome) for recoding and improving the nutritional status of participants.'}, {'measure': 'SGA-Questionnaire W30', 'timeFrame': '30th week', 'description': 'nutrition consultation and do the SGA questionnaire(the minimum value is 1 and the maximum value is 36. The higher scores mean a worse outcome) for recoding and improving the nutritional status of participants.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Personalized nutrition', 'Esophageal cancer', 'Concurrent chemoradiotherapy'], 'conditions': ['Esophageal Cancer', 'Personalized Nutrition']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to improve the nutritional status of esophageal cancer patients undergoing concurrent chemoradiotherapy by the personalized nutrition counseling.Dietitians consult with participants which invited to be the experimental group and follow up weekly through communication software (Line) or telephone remote methods. Dietitians provide the dietary advice base on the guidance of the cancer diet principles, and give on assessment and diet adjustments. At the same time, Under the same condition of nutritional supplements in both the experimental group and the control group, the investigators explore the changes in the quality of life and nutritional status of the subjects by evaluating with the nutrition Index (PG-SGA) and quality of life (EORTC QLQ-C30 questionnaire Taiwan version) questionnaire evaluation and recode the basic physical data, including body weight, grip strength, body muscle fat composition. Therefore, investigators conducted this study to appoint dietitian to arrange personalized nutrition consultation for esophageal cancer patients to improve the nutritional status of these patients.', 'detailedDescription': 'Approximately 60-85% of esophageal cancer patients present with malnutrition at diagnosis (1). Malnutrition, defined as body weight loss of more than 10% over the previous 6 months is associated with treatment response and survival (2). Around 38% of esophageal cancer patients are managed with curative intent in the form of neoadjuvant chemotherapy or chemoradiotherapy followed by esophagectomy (3). Individuals are at increased risk of malnutrition arising from disease related symptoms and neoadjuvant treatment. Nutritional status serves as an important risk factor for major complications after operation (4) Therefore, assessment of nutritional status should be undertaken for all esophageal cancer patients, especially for those who are planned to receive esophagectomy (5). The nutritional assessment includes hand grip for muscle mass (6), body composition for lean body mass and sarcopenia (7), body mass index- body weight loss grade (BMI-BWL grade) for generalized nutrition status (8). These tools are needed to be integrated and individualized to esophageal cancer patients to improve outcome. Therefore, investigators conducted this trial to appoint dietitian to arrange personalized nutrition consultation for esophageal cancer patients to improve the nutritional status of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Esophageal cancer or head and neck cancer patients undergoing concurrent chemoradiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pathologically and CT confirmed esophageal cancer or head and neck cancer\n2. CCRT therapy\n3. ECOG performance status gradeā¦2\n4. agree to participate the trial\n5. over 18 years\n6. no pregnant\n\nExclusion Criteria:\n\n1. have two or more cancers\n2. gastrointestinal tract cannot function\n3. NYHA class 4\n4. abnormal liver and kidney function\n5. Abnormal bone marrow hematopoiesis'}, 'identificationModule': {'nctId': 'NCT06829095', 'briefTitle': 'Personalized Nutrition Counseling and Nutritional Status of Esophageal Cancer and HNSCC Patients Undergoing CCRT', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Personalized Nutrition Counseling to Improve the Nutritional Status of Esophageal Cancer or Head and Neck Cancer Patients Undergoing Concurrent Chemoradiotherapy', 'orgStudyIdInfo': {'id': '202300755B0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'description': 'Under the same condition of nutritional supplements in both the experimental group and the control group,the investigators explore the changes in the quality of life and nutritional status of the subjects by evaluating with the nutrition Index (PG-SGA) and quality of life (EORTC QLQ-C30 questionnaire Taiwan version) questionnaire evaluation and recode the basic physical data, including body weight, grip strength, body muscle fat composition.'}, {'label': 'experimental', 'description': 'Dietitians consult with participants which invited to be the experimental group and follow up weekly through communication software (Line) or telephone remote methods. Dietitians provide the dietary advice base on the guidance of the cancer diet principles, and give on assessment and diet adjustments.Under the same condition of nutritional supplements in both the experimental group and the control group,the investigators explore the changes in the quality of life and nutritional status of the subjects by evaluating with the nutrition Index (PG-SGA) and quality of life (EORTC QLQ-C30 questionnaire Taiwan version) questionnaire evaluation and recode the basic physical data, including body weight, grip strength, body muscle fat composition.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '236', 'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hsuan-Chih Kuo', 'role': 'CONTACT', 'email': 'wisdom2000@gmail.com', 'phone': '0975366137'}, {'name': 'Chia-Hsun Hsieh', 'role': 'CONTACT', 'email': 'hsuanchihkuo@gmail.com', 'phone': '0975360665'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Chia-Hsun Hsieh', 'role': 'CONTACT', 'email': 'wisdom5000@gmail.com', 'phone': '0975366137'}, {'name': 'Hsuan-Chih Kuo', 'role': 'CONTACT', 'email': 'hsuanchihkuo@gmail.com', 'phone': '0975360665'}], 'overallOfficials': [{'name': 'Hsuan-Chih Kuo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Division of Oncology, Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Attending Physicians', 'investigatorFullName': 'Hsuan-Chih Kuo', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}