[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555319":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":231,"collaborators":25,"id":234,"slug":25,"hasResults":235,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":235,"sex":241,"minAge":242,"maxAge":243,"enrollmentInfo":244,"targetDuration":25,"studyType":247,"phases":248,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Goal-directed enteral nutritional therapy","EXPERIMENTAL","The participants will be administered a supervised goal-directed nutritional therapy. The enteral nutrition (EN) regimens include homemade meals with or without ORAL IMPACT® according to the daily goal.",[13],"Dietary Supplement: Goal-directed EN therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional enteral nutritional therapy","ACTIVE_COMPARATOR","The participants will be administered with an unsupervised and liberal nutritional support. The EN regimens will not include ORAL IMPACT®.",[19],"Dietary Supplement: Conventional EN therapy",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Goal-directed EN therapy",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Conventional EN therapy","The participants will be administered the conventional nutritional therapy according to the Chinese expert consensus on perioperative nutritional support in enhanced recovery after surgery (2019 edition).",[15],[31],{"name":32,"affiliation":5,"role":33},"Yin Li, M.D.","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Xiaozheng Kang, M.D.","CONTACT","+86 13910052790","kangxz@cicams.ac.cn",[41,58,70,82,94,105,113,125,136,144,156,164,176,184,196,207,219],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Cancer Hospital Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","100021","China",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":32,"role":37,"phone":56,"phoneExt":25,"email":57},"+86 (010) 87788052","liyin@cicams.ac.cn",{"facility":59,"status":43,"city":60,"state":61,"zip":25,"country":47,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Daping Hospital, Third Affiliated Hospital of Third Military Medical University","Chongqing","Chongqing Municipality",{"type":49,"coordinates":63},[64,65],106.55771,29.56026,{"lat":65,"lon":64},[68],{"name":69,"role":37,"phone":25,"phoneExt":25,"email":25},"Wei Guo, M.D.",{"facility":71,"status":43,"city":72,"state":73,"zip":25,"country":47,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Fujian Cancer Hospital","Fuzhou","Fujian",{"type":49,"coordinates":75},[76,77],119.30611,26.06139,{"lat":77,"lon":76},[80],{"name":81,"role":37,"phone":25,"phoneExt":25,"email":25},"Shuoyan Liu, M.D.",{"facility":83,"status":43,"city":84,"state":85,"zip":25,"country":47,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Anyang Cancer Hospital","Anyang","Henan",{"type":49,"coordinates":87},[88,89],114.38278,36.096,{"lat":89,"lon":88},[92],{"name":93,"role":37,"phone":25,"phoneExt":25,"email":25},"Anlin Hao, M.D.",{"facility":95,"status":43,"city":96,"state":85,"zip":25,"country":47,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"First Affiliated Hospital of Zhengzhou University","Zhengzhou",{"type":49,"coordinates":98},[99,100],113.64861,34.75778,{"lat":100,"lon":99},[103],{"name":104,"role":37,"phone":25,"phoneExt":25,"email":25},"Xiangnan Li, M.D.",{"facility":106,"status":43,"city":96,"state":85,"zip":25,"country":47,"cosmosGeoPoint":107,"geoPoint":109,"contacts":110},"Henan Cancer Hospital",{"type":49,"coordinates":108},[99,100],{"lat":100,"lon":99},[111],{"name":112,"role":37,"phone":25,"phoneExt":25,"email":25},"Yan Zheng, M.D.",{"facility":114,"status":43,"city":115,"state":116,"zip":25,"country":47,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Huai'an First People's Hospital","Huai'an","Jiangsu",{"type":49,"coordinates":118},[119,120],119.01917,33.58861,{"lat":120,"lon":119},[123],{"name":124,"role":37,"phone":25,"phoneExt":25,"email":25},"Jianqiang Zhao, M.D.",{"facility":126,"status":43,"city":127,"state":116,"zip":25,"country":47,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Jiangsu Cancer Hospital","Nanjing",{"type":49,"coordinates":129},[130,131],118.77778,32.06167,{"lat":131,"lon":130},[134],{"name":135,"role":37,"phone":25,"phoneExt":25,"email":25},"Feng Jiang, M.D.",{"facility":137,"status":43,"city":127,"state":116,"zip":25,"country":47,"cosmosGeoPoint":138,"geoPoint":140,"contacts":141},"Jiangsu Provincial People's Hospital",{"type":49,"coordinates":139},[130,131],{"lat":131,"lon":130},[142],{"name":143,"role":37,"phone":25,"phoneExt":25,"email":25},"Jinhua Luo, M.D.",{"facility":145,"status":43,"city":146,"state":147,"zip":25,"country":47,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Qilu Hospital of Shandong University","Jinan","Shandong",{"type":49,"coordinates":149},[150,151],116.99722,36.66833,{"lat":151,"lon":150},[154],{"name":155,"role":37,"phone":25,"phoneExt":25,"email":25},"Lin Li, M.D.",{"facility":157,"status":43,"city":146,"state":147,"zip":25,"country":47,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"Shandong Provincial Hospital",{"type":49,"coordinates":159},[150,151],{"lat":151,"lon":150},[162],{"name":163,"role":37,"phone":25,"phoneExt":25,"email":25},"Lin Zhang, M.D.",{"facility":165,"status":43,"city":166,"state":167,"zip":25,"country":47,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Shanghai Chest Hospital","Shanghai","Shanghai Municipality",{"type":49,"coordinates":169},[170,171],121.45806,31.22222,{"lat":171,"lon":170},[174],{"name":175,"role":37,"phone":25,"phoneExt":25,"email":25},"Zhigang Li, M.D.",{"facility":177,"status":43,"city":166,"state":167,"zip":25,"country":47,"cosmosGeoPoint":178,"geoPoint":180,"contacts":181},"Zhongshan Hospital Affiliated to Fudan University",{"type":49,"coordinates":179},[170,171],{"lat":171,"lon":170},[182],{"name":183,"role":37,"phone":25,"phoneExt":25,"email":25},"Lijie Tan, M.D.",{"facility":185,"status":43,"city":186,"state":187,"zip":25,"country":47,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Changzhi People's Hospital","Changzhi","Shanxi",{"type":49,"coordinates":189},[190,191],113.10528,36.18389,{"lat":191,"lon":190},[194],{"name":195,"role":37,"phone":25,"phoneExt":25,"email":25},"Changhong Lian, M.D.",{"facility":197,"status":43,"city":198,"state":187,"zip":25,"country":47,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Shanxi Cancer Hospital, Chinese Academy of Medical Sciences","Taiyuan",{"type":49,"coordinates":200},[201,202],112.56028,37.86944,{"lat":202,"lon":201},[205],{"name":206,"role":37,"phone":25,"phoneExt":25,"email":25},"Jianhong Lian, M.D.",{"facility":208,"status":43,"city":209,"state":210,"zip":25,"country":47,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","Tianjin Municipality",{"type":49,"coordinates":212},[213,214],117.17667,39.14222,{"lat":214,"lon":213},[217],{"name":218,"role":37,"phone":25,"phoneExt":25,"email":25},"Peng Tang, M.D.",{"facility":220,"status":43,"city":221,"state":222,"zip":25,"country":47,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Yunnan Cancer Hospital","Kunming","Yunnan",{"type":49,"coordinates":224},[225,226],102.71833,25.03889,{"lat":226,"lon":225},[229],{"name":230,"role":37,"phone":25,"phoneExt":25,"email":25},"Guangqiang Zhao, M.D.",{"type":33,"investigatorFullName":232,"investigatorTitle":233,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"YIN LI","Principal Investigator","100555319",false,"NCT06510543","Goal-directed Enteral Nutritional Perioperative Management","Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management","GENTLEMAN","Inclusion Criteria:\n\n1. Aged 18-80 years old;\n2. ECOG PS 0\\~1;\n3. NRS 2002 score ≥3;\n4. Malnutrition diagnosed according to the GLIM criteria;\n5. Histopathologically confirmed as esophageal squamous cell carcinoma;\n6. Primary tumors located in thoracic esophagus;\n7. Resectable locally advanced disease with clinical stage II to IVA (8th edition UICC\u002FAJCC) evaluated by a multidisciplinary team;\n8. Neoadjuvant therapy will be administered, which may entail preoperative chemo-radiotherapy, chemotherapy only, or a combination of immunotherapy such as anti-PD-1\u002FPD-L1;\n9. Informed consent for random assignment and completion of the protocol.\n\nExclusion Criteria:\n\n1. NRS 2002 score \\\u003C 3;\n2. Upfront surgery without neoadjuvant treatment;\n3. Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;\n4. Receiving any other nutritional support during the study;\n5. Unable to consume nutrition orally or receive it through tube feeding before surgery;\n6. History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;\n7. Severe abnormalities of liver and kidney functions (ALT≥2 times the upper limit of normal; Total bilirubin Tbil≥2 upper limit of normal; Creatinine Cr≥2 upper limit of normal);\n8. Metabolic disorders, including uncontrolled diabetes mellitus or fasting blood glucose ≥10mmol\u002FL, hypothyroidism, or hyperthyroidism;\n9. Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents\n10. History of known allergy to any component of ORAL IMPACT®;\n11. Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test at baseline or not using a reliable and appropriate contraceptive method;\n12. Refuse to sign the consent or unable to follow the study protocol;\n13. Inappropriate to participate in this study judged by investigators.","ALL","18 Years","80 Years",{"count":245,"type":246},400,"ESTIMATED","INTERVENTIONAL",[249],"NA","This clinical trial aims to determine whether perioperative goal-directed nutritional therapy can prevent postoperative pulmonary and other major complications in malnourished esophageal squamous cell cancer patients. Its main question is whether individualized nutritional therapy can improve short-term surgical outcomes and long-term prognosis. Researchers will compare goal-directed and conventional nutritional therapy to identify differences in morbidities and survival.",[252],"Esophagus Cancer",[254,255,256,257,258,259],"Esophageal Cancer","Esophagectomy","Nutritional Therapy","Morbidity","Survival","Malnourished","2024-07-14",{"date":262,"type":263},"2024-07-19","ACTUAL",{"date":265,"type":263},"2024-03-30",{"date":267,"type":246},"2031-05-30",{"name":5,"class":6},17]