Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-02 @ 8:38 AM
Study NCT ID:
NCT03286920
Status:
UNKNOWN
Last Update Posted:
2018-01-23
First Post:
2017-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D001835', 'term': 'Body Weight'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-19', 'studyFirstSubmitDate': '2017-09-15', 'studyFirstSubmitQcDate': '2017-09-15', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of 5% body weight loss on Day 30', 'timeFrame': 'Day 30 after discharge', 'description': 'Percentage of 5% body weight loss on Day 30 compared to the body weight at discharge'}], 'secondaryOutcomes': [{'measure': 'Completion ratio of different nutrition support approaches', 'timeFrame': 'Day 30 after discharge', 'description': 'Completion ratio of different nutrition support approaches'}, {'measure': 'Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale', 'timeFrame': 'Day30 and Day 90', 'description': "Assessment on patients' quality of life using EORTC QLQ-C30 scale and QLQ-OG25 scale in different nutrition support approach groups and investigate the relationship between different nutrition support approaches and patients' quality of life"}, {'measure': 'Complications of home enteral nutrition support', 'timeFrame': 'Day30', 'description': 'Assessment on complications of home enteral nutrition support'}, {'measure': 'Delay and interruption ratio of adjuvant treatment', 'timeFrame': 'Day 30 and Day 90', 'description': 'Delay and interruption ratio of adjuvant treatment including whether chemotherapy and radiotherapy can be implemented on time'}, {'measure': 'Re-hospitalization ratio', 'timeFrame': 'Day 90', 'description': 'Re-hospitalization ratio within 90 days after discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['home nutrition', 'BMI', 'postoperative', 'body weight'], 'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'This clinical trial is designed to be a multi-center prospective observational study which shall compare the effect of different postoperative home nutrition modes on recent nutritional index (weight/BMI) of patients with esophageal cancer and recent outcomes. Different postoperative home nutrition modes adopted in this study includes oral natural diet, oral nutrition supplement and tube feeding.', 'detailedDescription': 'STUDY BACKGROUND Esophageal cancer is a common cancer in China and due to its influence on diet intake, patients with esophageal cancer are often combined with nutrition deficiency, which causes relatively high nutrition risk to treatment. Studies conducted by Martin et al showed that the degree of body weight loss in patients with malignancy is related to BMI level and prognosis. The patients with severe body weight loss and low BMI have poor prognosis, especially for patients with esophageal cancer.\n\nAt present, perioperative nutrition support for patients with esophageal cancer has been recognized and has been recommended as routine in 2017 NCCN guideline. How to implement good home nutrition within one month after patient discharge and recover nutrition index as soon as possible has become a focus for esophageal surgeon.\n\nMany clinical trials have already investigated enteral nutrition support approach during anti-cancer treatment period in patients with malignancy. However, only a few clinical trials are good designed. Therefore the investigators hope to via this multi-center prospective observational study to provide evidence for this question.\n\nOBJECTIVES:\n\n1. To explore the relationship between postoperative home nutrition support treatment approach and nutritional status of patients with esophageal cancer;\n2. To explore the relationship between postoperative home nutrition support treatment approach and recent prognosis in patients with esophageal cancer;\n3. To promote the standardized application of postoperative home nutrition support treatment for patients with esophageal cancer.\\\\\n\nOUTLINE:\n\nIncluded patients shall be divided into three groups according to the treatment plan of all centers, including oral natural diet, oral nutrition supplement and tube feeding. As for patients in oral natural diet group, the patients shall receive oral natural diet. As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d. As for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding enteral supplement providing 750-1500kcal/d.\n\nAll the included patients shall be followed up weekly within 1-3 weeks after discharge via telephone, at Day 30 after discharge and at Day 90 after discharge to assess the effectiveness and safety of different home nutrition supplement approaches.\n\nPROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with esophageal cancer who undergo surgery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age below 80 years old;\n* Esophageal cancer;\n* Radical surgery;\n* Normal gastrointestinal function\n\nExclusion Criteria:\n\n* Patients with diabetes and poor blood glucose control;\n* Patients with severe postoperative complications;\n* Patients who can't tolerate lactose;\n* Patients who decline inclusion and follow-ups"}, 'identificationModule': {'nctId': 'NCT03286920', 'briefTitle': 'Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer', 'orgStudyIdInfo': {'id': '2017-06-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oral natural diet', 'description': 'As for patients in oral natural diet group, the the participants shall receive oral natural diet.'}, {'label': 'Oral nutrition supplement group', 'description': 'As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.', 'interventionNames': ['Dietary Supplement: Oral nutrition supplement']}, {'label': 'Tube feeding nutrition supplement group', 'description': 'As for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding nutrition supplement providing 750-1500kcal/d.', 'interventionNames': ['Dietary Supplement: Tube feeding nutrition supplement']}], 'interventions': [{'name': 'Oral nutrition supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.', 'armGroupLabels': ['Oral nutrition supplement group']}, {'name': 'Tube feeding nutrition supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'As for patients in tube feeding group, in addition to oral natural die, the participants shall receive Tube feeding nutrition supplement providing 750-1500kcal/d.', 'armGroupLabels': ['Tube feeding nutrition supplement group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bengbu', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Geng, Master', 'role': 'CONTACT', 'email': '495922402@qq.com', 'phone': '+86 15755235970'}], 'facility': 'First Affiliated Hospital Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zaicheng Yu, Master', 'role': 'CONTACT', 'email': '13705699600@163.com', 'phone': '+86 13705699600'}, {'name': 'Renquan Zhang, Master', 'role': 'CONTACT', 'email': 'zhangrenquan@live.cn', 'phone': '+86 13505693475'}], 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Keneng Chen, M.D.', 'role': 'CONTACT', 'email': 'chenkeneng@bjmu.edu.cn', 'phone': '+86 13501085973'}, {'name': 'Liang Dai, M.D.', 'role': 'CONTACT', 'email': 'dailiangsharp_26@aliyun.com', 'phone': '+86 18610065191'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Deruo Liu, M.D.', 'role': 'CONTACT', 'email': 'fenghongxiang617@126.com', 'phone': '+86 13801186957'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhipeng Ren, M.D.', 'role': 'CONTACT', 'email': 'renzhipeng04@163.com', 'phone': '+86 15901297308'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Guo, M.D.', 'role': 'CONTACT', 'email': 'gyguowei@hotmail.com', 'phone': '+86 13527323568'}], 'facility': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chun Chen, M.D.', 'role': 'CONTACT', 'email': 'chenchun0209@163.com', 'phone': '+86 13365910325'}], 'facility': 'Union hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangdong', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenfeng Ye, M.D.', 'role': 'CONTACT', 'email': 'gzyewf@hotmai.com', 'phone': '+86 13902266462'}], 'facility': 'Sun Yat-sen University Cancer Hospital'}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guibin Qiao, M.D.', 'role': 'CONTACT', 'email': 'guibinqiao@126.com', 'phone': '+86 13602749153'}], 'facility': 'Guangzhou General Hospital of Guangzhou Military Command', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming He, M.D.', 'role': 'CONTACT', 'email': 'heming6699@sina.com', 'phone': '+86 13833187902'}], 'facility': 'Hebei Medical University Fourth Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianqun Ma, M.D.', 'role': 'CONTACT', 'email': 'jianqunma@aliyun.com', 'phone': '+86 13359990466'}], 'facility': 'The Third Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Anyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaotian Shi, M.D.', 'role': 'CONTACT', 'email': 'shxt531216sh@163.com', 'phone': '+86 13703725817'}], 'facility': 'Anyang Tumor Hospital', 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangning Fu, M.D.', 'role': 'CONTACT', 'email': 'fuxn2006@aliyun.com', 'phone': '+86 13607150390'}], 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenliang Liu, M.D.', 'role': 'CONTACT', 'email': 'liuwenliang1859@163.com', 'phone': '+86 13507438708'}], 'facility': 'Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Youbin Cui, M.D.', 'role': 'CONTACT', 'email': 'cuiyb@jlu.edu.cn', 'phone': '+86 13364513508'}], 'facility': 'First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongxu Liu, M.D.', 'role': 'CONTACT', 'phone': '+86 13840004476'}], 'facility': 'Liaoning Tumor Hospital & Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Tian, M.D.', 'role': 'CONTACT', 'email': 'tianhuiql@126.com', 'phone': '+86 13791122838'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhou Wang, M.D.', 'role': 'CONTACT', 'email': 'wz620226@hotmail.com', 'phone': '+86 13665312567'}], 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Hu, Master', 'role': 'CONTACT', 'email': 'huhong0997@163.com', 'phone': '+86 13512102066'}], 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhigang Li, M.D.', 'role': 'CONTACT', 'email': 'dr_lizhigang@hotmail.com', 'phone': '+86 13816121518'}], 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shiping Guo, Master', 'role': 'CONTACT', 'email': 'chunhua527@126.com', 'phone': '+86 13700541808'}], 'facility': 'Shanxi Province Cancer Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Kunming', 'state': 'Yunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang Bu, M.D.', 'role': 'CONTACT', 'email': 'thoracicsurgeon@vip.sina.com', 'phone': '+86 13611000133'}], 'facility': "First People's Hospital of Yunan province", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Hanzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qixun Chen, M.D>', 'role': 'CONTACT', 'email': 'chenqixun64@sina.com', 'phone': '+86 13958108371'}], 'facility': 'Zhejiang Cancer Hospital'}], 'centralContacts': [{'name': 'Keneng Chen, M.D.', 'role': 'CONTACT', 'email': 'chenkeneng@bjmu.edu.cn', 'phone': '+86 13501085973'}, {'name': 'Liang Dai, M.D.', 'role': 'CONTACT', 'email': 'dailiangsharp_26@aliyun.com', 'phone': '+86 18610065191'}], 'overallOfficials': [{'name': 'Keneng Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'Hebei Medical University Fourth Hospital', 'class': 'OTHER'}, {'name': 'Anyang Tumor Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Bengbu Medical University', 'class': 'OTHER'}, {'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': 'Shanxi Province Cancer Hospital', 'class': 'OTHER'}, {'name': 'The Third Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'Liaoning Cancer Hospital & Institute', 'class': 'OTHER'}, {'name': 'Wuhan General Hospital of Guangzhou Military Command', 'class': 'OTHER'}, {'name': 'Second Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': "Hunan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Union hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Ke-Neng Chen, MD, PhD, FRCS', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}