[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507820":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":294,"collaborators":298,"id":325,"slug":326,"hasResults":327,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":26,"eligibilityCriteria":331,"healthyVolunteers":327,"sex":332,"minAge":333,"maxAge":334,"enrollmentInfo":335,"targetDuration":26,"studyType":338,"phases":339,"briefSummary":341,"conditions":342,"keywords":344,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":358},{"fullName":5,"class":6},"First Affiliated Hospital of Guangxi Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immunonutrition Group","EXPERIMENTAL","Induction chemotherapy (IC) + Concurrent chemoradiotherapy (CCRT) and enteral immunonutrition\n\nPatients receive gemcitabine (1000 mg\u002Fm² d1,8) and cisplatin (80mg\u002Fm² d1) every 3 weeks for 2-3 cycles before radiotherapy and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin (100mg\u002Fm² d1) every 3 weeks for 2-3 cycles.\n\nPatients receive enteral immunonutrition, Oral Impact®, Nestle, 250ml\u002F bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.",[13],"Dietary Supplement: Enteral immunonutrition",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Induction chemotherapy+Concurrent chemoradiotherapy and standard enteral nutrition\n\nPatients receive gemcitabine (1000 mg\u002Fm² d1,8) and cisplatin (80mg\u002Fm² d1) every 3 weeks for 2-3 cycles before radiotherapy and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin(100mg\u002Fm² d1) every 3 weeks for 2-3 cycles.\n\nPatients receive isocaloric standard enteral nutrition formula (ENSURE®), 250 mL per administration, 3 times per day, from 5 days before radiotherapy to the end of radiotherapy. Preparation of the 250 mL dose involves adding 200 mL of potable water to a cup and slowly stirring in 52.7 g of ENSURE powder (approximately 6 scoops).",[19],"Dietary Supplement: Standard enteral nutrition",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Enteral immunonutrition","Enteral immunonutrition (Oral Impact®, Nestle), 250ml\u002F bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard enteral nutrition","Isocaloric standard enteral nutrition formula (ENSURE®)， 250 mL per administration, 3 times per day. Preparation of the 250 mL dose involves adding 200 mL of potable water to a cup and slowly stirring in 52.7 g of ENSURE powder (approximately 6 scoops).",[15],[32],{"name":33,"affiliation":34,"role":35},"Min Kang, M.D","Department of Radiation Oncology, The First Affiliated Hospital of Guangxi Medical University","STUDY_CHAIR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Zhen Meng, M.D","CONTACT","86-771-5356509","mengzhen0307@163.com",{"name":43,"role":39,"phone":40,"phoneExt":26,"email":44},"Yating Qin, M.D","qyt201680138@163.com",[46,65,75,90,100,114,128,140,154,167,179,188,201,211,222,236,246,259,273,283],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Fujian Provincial Hospital","RECRUITING","Fuzhou","Fujian","350000","China","CN",{"type":55,"coordinates":56},"Point",[57,58],119.30611,26.06139,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":63,"phoneExt":26,"email":64},"Jingbo Chen, MD","+86 591 8821 8888","13635294192@163.com",{"facility":66,"status":48,"city":49,"state":50,"zip":67,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Fujian Cancer Hospital","350014",{"type":55,"coordinates":69},[57,58],{"lat":58,"lon":57},[72],{"name":73,"role":39,"phone":26,"phoneExt":26,"email":74},"Yun Xu, MD","308466040@qq.com",{"facility":76,"status":48,"city":77,"state":78,"zip":79,"country":52,"countryCode":53,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Guangdong Provincial People's Hospital","Guangzhou","Guangdong","510060",{"type":55,"coordinates":81},[82,83],113.25,23.11667,{"lat":83,"lon":82},[86],{"name":87,"role":39,"phone":88,"phoneExt":26,"email":89},"Dehuan Xie, MD","+86 20 8382 7812","xiedehuan@gdph.org.cn",{"facility":91,"status":48,"city":77,"state":78,"zip":92,"country":52,"countryCode":53,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"Affiliated Cancer Hospital & Institute of Guangzhou Medical University","510070",{"type":55,"coordinates":94},[82,83],{"lat":83,"lon":82},[97],{"name":98,"role":39,"phone":99,"phoneExt":26,"email":26},"Mingyi Li, MD","+86 20 8359 5032",{"facility":101,"status":48,"city":102,"state":78,"zip":103,"country":52,"countryCode":53,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Huizhou Municipal Central Hospital","Huizhou","516001",{"type":55,"coordinates":105},[106,107],114.41523,23.11147,{"lat":107,"lon":106},[110],{"name":111,"role":39,"phone":112,"phoneExt":26,"email":113},"Ying Shao, MD","+86 752 217 8126","shaoying8718@163.com",{"facility":115,"status":48,"city":116,"state":117,"zip":118,"country":52,"countryCode":53,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"The Affiliated Hospital of Guilin Medical University","Guilin","Guangxi","541001",{"type":55,"coordinates":120},[121,122],110.29639,25.28022,{"lat":122,"lon":121},[125],{"name":126,"role":39,"phone":127,"phoneExt":26,"email":26},"Meilian Liu","+86 773 283 3086",{"facility":129,"status":48,"city":130,"state":117,"zip":131,"country":52,"countryCode":53,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Liuzhou Workers Hospital","Liuzhou","545025",{"type":55,"coordinates":133},[134,135],109.40698,24.32405,{"lat":135,"lon":134},[138],{"name":139,"role":39,"phone":26,"phoneExt":26,"email":26},"Zhuohua Xu, MS",{"facility":141,"status":48,"city":142,"state":117,"zip":143,"country":52,"countryCode":53,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"The First Affiliated Hospital of Guangxi Medical University","Nanning","530000",{"type":55,"coordinates":145},[146,147],108.31667,22.81667,{"lat":147,"lon":146},[150,152],{"name":38,"role":39,"phone":151,"phoneExt":26,"email":41},"07715356509",{"name":43,"role":39,"phone":151,"phoneExt":26,"email":153},"937125122@qq.com",{"facility":155,"status":48,"city":156,"state":117,"zip":157,"country":52,"countryCode":53,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Wuzhou Red Cross Hospital","Wuzhou","543002",{"type":55,"coordinates":159},[160,161],111.28848,23.48054,{"lat":161,"lon":160},[164],{"name":165,"role":39,"phone":166,"phoneExt":26,"email":26},"Lingling Fan, MS","+86 774 382 3120",{"facility":168,"status":48,"city":169,"state":117,"zip":170,"country":52,"countryCode":53,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"First People People's Hospital of Yulin City","Yulin","537001",{"type":55,"coordinates":172},[173,174],110.14686,22.6305,{"lat":174,"lon":173},[177],{"name":178,"role":39,"phone":26,"phoneExt":26,"email":26},"Leifeng Liang, MD",{"facility":180,"status":48,"city":169,"state":117,"zip":181,"country":52,"countryCode":53,"cosmosGeoPoint":182,"geoPoint":184,"contacts":185},"Red Cross Hospital of Yulin City","537006",{"type":55,"coordinates":183},[173,174],{"lat":174,"lon":173},[186],{"name":187,"role":39,"phone":166,"phoneExt":26,"email":26},"Shuang Li, MS",{"facility":101,"status":48,"city":189,"state":190,"zip":191,"country":52,"countryCode":53,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Haikou","Hainan","570208",{"type":55,"coordinates":193},[194,195],110.34651,20.03421,{"lat":195,"lon":194},[198],{"name":199,"role":39,"phone":200,"phoneExt":26,"email":26},"Feng Yuan, MD","+86 898 6615 1001",{"facility":202,"status":48,"city":189,"state":190,"zip":203,"country":52,"countryCode":53,"cosmosGeoPoint":204,"geoPoint":206,"contacts":207},"The Second Affiliated Hospital of Hainan Medical University","570311",{"type":55,"coordinates":205},[194,195],{"lat":195,"lon":194},[208],{"name":209,"role":39,"phone":210,"phoneExt":26,"email":26},"Junnv Xu, MD","+86 898 6680 9130",{"facility":212,"status":48,"city":189,"state":190,"zip":213,"country":52,"countryCode":53,"cosmosGeoPoint":214,"geoPoint":216,"contacts":217},"Hainan Cancer Hospital","570314",{"type":55,"coordinates":215},[194,195],{"lat":195,"lon":194},[218],{"name":219,"role":39,"phone":220,"phoneExt":26,"email":221},"Pingting Zhou, MD","+86 898 6855 2139","18689525165@163.com",{"facility":223,"status":48,"city":224,"state":225,"zip":226,"country":52,"countryCode":53,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Second Affiliated Hospital of Nanchang University","Nanchang","Jiangxi","330000",{"type":55,"coordinates":228},[229,230],115.85306,28.68396,{"lat":230,"lon":229},[233],{"name":234,"role":39,"phone":235,"phoneExt":26,"email":26},"Jianwu Ding, MD","+86 791 8629 7662",{"facility":237,"status":48,"city":224,"state":225,"zip":238,"country":52,"countryCode":53,"cosmosGeoPoint":239,"geoPoint":241,"contacts":242},"The First Affiliated Hospital of Nanchang University","330209",{"type":55,"coordinates":240},[229,230],{"lat":230,"lon":229},[243],{"name":244,"role":39,"phone":26,"phoneExt":26,"email":245},"Shaoqing Chen, MD","7687105701@qq.com",{"facility":247,"status":48,"city":248,"state":249,"zip":250,"country":52,"countryCode":53,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Qingdao Central Hospital","Qingdao","Shandong","266044",{"type":55,"coordinates":252},[253,254],120.38042,36.06488,{"lat":254,"lon":253},[257],{"name":258,"role":39,"phone":26,"phoneExt":26,"email":26},"Xiaotao Zhang, MD",{"facility":260,"status":48,"city":261,"state":262,"zip":263,"country":52,"countryCode":53,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"Zhejiang Provincial Tongde Hospital","Hangzhou","Zhejiang","310012",{"type":55,"coordinates":265},[266,267],120.16142,30.29365,{"lat":267,"lon":266},[270],{"name":271,"role":39,"phone":272,"phoneExt":26,"email":26},"Zhongzhu Tang, MD","+86 571 8992 0000",{"facility":274,"status":48,"city":261,"state":262,"zip":275,"country":52,"countryCode":53,"cosmosGeoPoint":276,"geoPoint":278,"contacts":279},"Zhejiang Provincial People's Hospital","310014",{"type":55,"coordinates":277},[266,267],{"lat":267,"lon":266},[280],{"name":281,"role":39,"phone":26,"phoneExt":26,"email":282},"limin Luo, MD","21259400@qq.com",{"facility":284,"status":48,"city":261,"state":262,"zip":285,"country":52,"countryCode":53,"cosmosGeoPoint":286,"geoPoint":288,"contacts":289},"Zhejiang Cancer Hospital","310022",{"type":55,"coordinates":287},[266,267],{"lat":267,"lon":266},[290],{"name":291,"role":39,"phone":292,"phoneExt":26,"email":293},"Yonghong Hua, MD","+86 571 8812 8218","nc.gro.ccjz@yquh.com",{"type":295,"investigatorFullName":296,"investigatorTitle":297,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","min kang","Professor",[299,300,301,302,304,305,307,308,309,310,311,312,314,315,316,318,320,321,322,324],{"name":76,"class":6},{"name":284,"class":6},{"name":274,"class":6},{"name":66,"class":303},"OTHER_GOV",{"name":47,"class":6},{"name":306,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"name":237,"class":6},{"name":223,"class":6},{"name":91,"class":6},{"name":247,"class":6},{"name":101,"class":6},{"name":313,"class":6},"Haikou People's Hospital",{"name":202,"class":6},{"name":260,"class":6},{"name":317,"class":6},"Guilin Medical University, China",{"name":319,"class":303},"Liuzhou Workers' Hospital",{"name":155,"class":6},{"name":180,"class":6},{"name":323,"class":6},"First People's Hospital of Yulin",{"name":212,"class":6},"100507820","effect-of-immunonutrients-on-oral-mucositis-in-nasopharyngeal-carcinoma-patients-after-chemoradiotherapy-100507820",false,"NCT05892354","Effect of Immunonutrients on Oral Mucositis in Nasopharyngeal Carcinoma Patients After Chemoradiotherapy","Efficacy of Immunonutrients in Reducing Oral Mucositis in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective, Multicenter, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n2. Age 18-70 years old, male or non-pregnant women;\n3. Pathologically confirmed non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated,WHO type II or III);\n4. Newly diagnosed stage III-IVa (8th AJCC\u002FUICC stage) NPC patients;\n5. The levels of major organ function meet the following criteria:\n\n(1)Hematology: WBC ≥ 3.0 × 10\\^9\u002FL, ANC ≥ 1.5 × 10\\^9\u002FL, PLT ≥ 100 × 10\\^9\u002FL, HGB ≥ 90 g\u002FL; (2) Liver function: ALT, AST≤2.5 times the upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN; (3) Renal function: BUN and CRE ≤ 1.5 × ULN or an estimated glomerular filtration rate (eGFR) ≥ 60 ml\u002Fmin (calculated using the Cockcroft-Gault equation); (4) Adequate coagulation function: defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the ULN; (5) Normal levels of cardiac enzymes; 6. The patient has signed informed consent forms and is able to comply with the study's planned visits, treatment plans, and laboratory tests.\n\nExclusion Criteria:\n\n1. History of investigational Oral Impact®\u002FENSURE® use within the month prior to enrollment;\n2. Known allergy or intolerance to any component of investigational Oral Impact®\u002FENSURE® or related chemotherapy drugs;\n3. Poor glycemic control in patients with diabetes;\n4. Patients with autoimmune diseases;\n5. Patients with active infections;\n6. Patients who have received radiation therapy or other anti-tumor treatments in the past;\n7. Patients with a history of other malignant tumors;\n8. Presence of oral mucositis at baseline;\n9. Malnutrition at baseline;\n10. Patients who cannot eat the required amount of food at baseline and require parenteral or enteral nutrition;\n11. Inability to eat soft solid foods at baseline;\n12. History of human immunodeficiency virus (HIV) or active hepatitis B\u002FC virus infection;\n13. Participation in other intervention clinical studies within one month;\n14. Subjects deemed by the investigator to have other factors that may force them to terminate the study, such as having other serious illnesses (including mental illnesses) that require concomitant treatment, significantly abnormal laboratory test results, or family or social factors that may affect subject safety or data collection.","ALL","18 Years","70 Years",{"count":336,"type":337},190,"ESTIMATED","INTERVENTIONAL",[340],"NA","The purpose of this study was to investigate the role of immunonutrion compared with standard nutrition in reducing oral mucositis in patients with locally advanced nasopharyngeal carcinoma.",[343],"Locally Advanced Nasopharyngeal Carcinoma",[345,346,347,348],"Immunonutrition","Nasopharyngeal Carcinoma","Chemoradiotherapy","Oral Mucositis","2024-08-05",{"date":351,"type":352},"2024-08-07","ACTUAL",{"date":354,"type":352},"2023-06-12",{"date":356,"type":337},"2027-04-01",{"name":5,"class":6},20]