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

Recruiting now · Not applicable

Conditions studied: Locally Advanced Nasopharyngeal Carcinoma

In brief

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.

Key facts

Study ID

NCT05892354

Run by

First Affiliated Hospital of Guangxi Medical University

People needed

190

Starts

2023-06-12

Expected to finish

2027-04-01

Last updated by the study team

2024-08-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fujian Provincial Hospital — Fuzhou, Fujian, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
• Huizhou Municipal Central Hospital — Huizhou, Guangdong, China (enrolling)
• The Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China (enrolling)
• Liuzhou Workers Hospital — Liuzhou, Guangxi, China (enrolling)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
• Wuzhou Red Cross Hospital — Wuzhou, Guangxi, China (enrolling)
• First People People's Hospital of Yulin City — Yulin, Guangxi, China (enrolling)
• Red Cross Hospital of Yulin City — Yulin, Guangxi, China (enrolling)
• Huizhou Municipal Central Hospital — Haikou, Hainan, China (enrolling)
• The Second Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (enrolling)
• Hainan Cancer Hospital — Haikou, Hainan, China (enrolling)
• Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• Qingdao Central Hospital — Qingdao, Shandong, China (enrolling)
• Zhejiang Provincial Tongde Hospital — Hangzhou, Zhejiang, China (enrolling)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (enrolling)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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