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
First Affiliated Hospital of Guangxi Medical University
190 participants
Jun 12, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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;
- 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 Criteria14
- 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;
- Patients with active infections;
- Patients who have received radiation therapy or other anti-tumor treatments in the past;
- Patients with a history of other malignant tumors;
- Presence of oral mucositis at baseline;
- Malnutrition at baseline;
- Patients who cannot eat the required amount of food at baseline and require parenteral or enteral nutrition;
- Inability to eat soft solid foods at baseline;
- History of human immunodeficiency virus (HIV) or active hepatitis B/C virus infection;
- Participation in other intervention clinical studies within one month;
- 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.
Interventions
Enteral immunonutrition (Oral Impact®, Nestle), 250ml/ bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.
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).
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT05892354