First Affiliated Hospital of Guangxi Medical University
Phase
Not applicable
Started
2023-06-12
Last updated
2024-08-07
Condition(s) studied
Locally Advanced Nasopharyngeal Carcinoma
Investigational drug(s) / intervention(s)
Enteral immunonutritionStandard enteral nutrition
Enteral immunonutrition: Enteral immunonutrition (Oral Impact®, Nestle), 250ml/ bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.
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).
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
2. Age 18-70 years old, male or non-pregnant women;
3. Pathologically confirmed non-keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated,WHO type II or III);
4. Newly diagnosed stage III-IVa (8th AJCC/UICC stage) NPC patients;
5. The levels of major organ function meet the following criteria:
(1)Hematology: WBC ≥ 3.0 × 10\^9/L, ANC ≥ 1.5 × 10\^9/L, PLT ≥ 100 × 10\^9/L, HGB ≥ 90 g/L; (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/min (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.
Exclusion Criteria:
1. History of investigational Oral Impact®/ENSURE® use within the month prior to enrollment;
2. Known allergy or intolerance to any component of investigational Oral Impact®/ENSURE® or related chemotherapy drugs;
3. Poor glycemic control in patients with diabetes;
4. Patients with autoimmune diseases;
5. Patients with active infections;
6. Patients who have received radiation therapy or other anti-tumor treatments in the past;
7. Patients with a history of other malignant tumors;
8. Presence of oral mucositis at baseline;
9. Malnutrition at baseline;
10. Patients who cannot eat the required amount of food at baseline and require parenteral or enteral nutrition;
11. Inability to eat soft solid foods at baseline;
12. History of human immunodeficiency virus (HIV) or active hepatitis B/C virus infection;
13. Participation in other intervention clinical studies within one month;
14. 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.
Primary outcome measure(s)
The incidence of severe oral mucositis — 7 weeks Incidence of grade 3-4 oral mucositis
Trial sites (20)
Facility
City
Region
Status
Fujian Provincial Hospital
Fuzhou
Fujian
Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
Recruiting
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
Huizhou Municipal Central Hospital
Huizhou
Guangdong
Recruiting
The Affiliated Hospital of Guilin Medical University
Guilin
Guangxi
Recruiting
Liuzhou Workers Hospital
Liuzhou
Guangxi
Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning
Guangxi
Recruiting
Wuzhou Red Cross Hospital
Wuzhou
Guangxi
Recruiting
First People People's Hospital of Yulin City
Yulin
Guangxi
Recruiting
Red Cross Hospital of Yulin City
Yulin
Guangxi
Recruiting
Huizhou Municipal Central Hospital
Haikou
Hainan
Recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou
Hainan
Recruiting
Hainan Cancer Hospital
Haikou
Hainan
Recruiting
Second Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Recruiting
Qingdao Central Hospital
Qingdao
Shandong
Recruiting
Zhejiang Provincial Tongde Hospital
Hangzhou
Zhejiang
Recruiting
Zhejiang Provincial People's Hospital
Hangzhou
Zhejiang
Recruiting
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
Recruiting
More First Affiliated Hospital of Guangxi Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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