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Using immunonutrition to reduce oral mucositis in nasopharyngeal carcinoma patients after treatment

Efficacy of Immunonutrients in Reducing Oral Mucositis in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective, Multicenter, Randomized Controlled Clinical Trial

Not applicable Interventional First Affiliated Hospital of Guangxi Medical University · NCT05892354

This study is testing if a special type of nutrition can help reduce painful mouth sores in patients with nasopharyngeal cancer who are getting treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment190 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorFirst Affiliated Hospital of Guangxi Medical University Academic / other
Drugs / interventionschemotherapy, radiation
Locations20 sites (Fuzhou, Fujian and 19 other locations)
Trial IDNCT05892354 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of immunonutrition compared to standard nutrition in reducing oral mucositis among patients with locally advanced nasopharyngeal carcinoma undergoing chemoradiotherapy. Oral mucositis is a common and painful side effect of treatment, affecting patients' ability to eat and their overall quality of life. The study aims to determine if immunonutrition can lower the incidence and severity of this condition, thereby improving nutritional status and treatment tolerance. Participants will receive either enteral immunonutrition or standard enteral nutrition during their treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed stage III-IVa nasopharyngeal carcinoma and an ECOG performance status of 0-1.

Not a fit: Patients with conditions that severely compromise organ function or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the severity of oral mucositis and improve the quality of life for patients undergoing treatment for nasopharyngeal carcinoma.

How similar studies have performed: Previous studies have shown that immunonutrition can reduce the incidence of severe oral mucositis in head and neck cancer patients, suggesting potential for success in this study.

Eligibility criteria

Show full inclusion / exclusion 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 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.

Where this trial is running

Fuzhou, Fujian and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Locally Advanced Nasopharyngeal CarcinomaImmunonutritionNasopharyngeal CarcinomaChemoradiotherapyOral Mucositis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.