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.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
Age 18-70 years old, male or non-pregnant women;
Pathologically confirmed non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated,WHO type II or III);
Newly diagnosed stage III-IVa (8th AJCC/UICC stage) NPC patients;
History of investigational Oral Impact®/ENSURE® use within the month prior to enrollment;
Known allergy or intolerance to any component of investigational Oral Impact®/ENSURE® or related chemotherapy drugs;
Poor glycemic control in patients with diabetes;
Patients with autoimmune diseases;
Parallel
Enteral immunonutrition
Dietary supplementEnteral immunonutrition (Oral Impact®, Nestle), 250ml/ bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.
Standard enteral nutrition
Dietary supplementIsocaloric 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).
The incidence of severe oral mucositis
Incidence of grade 3-4 oral mucositis
The latency period of severe oral mucositis
Total duration from the start of radiotherapy to the severe oral mucositis
The duration period of severe oral mucositis
The number of days of severe oral mucositis during the oral mucositis observation period
Assessment of immune state
T-lymphocyte subsets
Serum hypersensitive C-reactive protein (hsCRP) level
Change in high sensitivity C-reactive protein from baseline to end of radiotherapy
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First Affiliated Hospital of Guangxi Medical University
Lead sponsor
Guangdong Provincial People's Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Zhejiang Provincial People's Hospital
Collaborator
Fujian Cancer Hospital
Collaborator
Fujian Provincial Hospital
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborator
Qingdao Central Hospital
Collaborator
Huizhou Municipal Central Hospital
Collaborator
Haikou People's Hospital
Collaborator
The Second Affiliated Hospital of Hainan Medical University
Collaborator
Zhejiang Provincial Tongde Hospital
Collaborator
Guilin Medical University, China
Collaborator
Liuzhou Workers' Hospital
Collaborator
Wuzhou Red Cross Hospital
Collaborator
Red Cross Hospital of Yulin City
Collaborator
First People's Hospital of Yulin
Collaborator
Hainan Cancer Hospital
Collaborator
