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Recruiting NCT05892354

Effect of Immunonutrients on Oral Mucositis in Nasopharyngeal Carcinoma Patients After Chemoradiotherapy

Trial Parameters

Condition Locally Advanced Nasopharyngeal Carcinoma
Sponsor First Affiliated Hospital of Guangxi Medical University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 190
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2023-06-12
Completion 2025-04-30
Interventions
Enteral immunonutritionStandard enteral nutrition

Brief 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 Criteria

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 wit

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