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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fujian Provincial Hospital
  Fuzhou, Fujian, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• Huizhou Municipal Central Hospital
  Huizhou, Guangdong, China Recruiting
• The Affiliated Hospital of Guilin Medical University
  Guilin, Guangxi, China Recruiting

Study contacts

• Study coordinator: Zhen Meng, M.D
• Email: mengzhen0307@163.com
• Phone: 86-771-5356509

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two versus three cycles of chemotherapy for advanced nasopharyngeal cancer

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• Combining Envafolimab with Chemoradiotherapy for Advanced Nasopharyngeal Cancer

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• Comparing two treatment approaches for advanced nasopharyngeal cancer

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  Recruiting Phase 3 First Affiliated Hospital, Sun Yat-Sen University · Guangzhou, Guangdong · NCT05062005

• Combining SBRT, chemotherapy, and tislelizumab for metastatic nasopharyngeal carcinoma

  This study is testing if combining a type of targeted radiation therapy, chemotherapy, and an immune booster can help people with advanced nasopharyngeal cancer feel better and live longer.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.