RecruitingNot ApplicableNCT05892354

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


Sponsor

First Affiliated Hospital of Guangxi Medical University

Enrollment

190 participants

Start Date

Jun 12, 2023

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding immune-boosting nutritional supplements (immunonutrients) during chemotherapy and radiation can reduce mouth sores (oral mucositis) in patients being treated for nasopharyngeal cancer (cancer at the back of the nose and throat). **You may be eligible if...** - You are between 18 and 70 years old - You have newly diagnosed nasopharyngeal carcinoma (WHO type II or III), confirmed by biopsy - Your cancer is stage II–IVB - You are in good general health (ECOG score 0 or 1) **You may NOT be eligible if...** - Your cancer has spread beyond the nasopharynx with distant metastases - You are pregnant - You have had previous treatment for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTEnteral immunonutrition

Enteral immunonutrition (Oral Impact®, Nestle), 250ml/ bottle, 2 bottles per day, from 5 days before radiotherapy to the end of radiotherapy.

DIETARY_SUPPLEMENTStandard enteral nutrition

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)

Fujian Provincial Hospital

Fuzhou, Fujian, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Huizhou Municipal Central Hospital

Huizhou, Guangdong, China

The Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Liuzhou Workers Hospital

Liuzhou, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

First People People's Hospital of Yulin City

Yulin, Guangxi, China

Red Cross Hospital of Yulin City

Yulin, Guangxi, China

Huizhou Municipal Central Hospital

Haikou, Hainan, China

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Hainan Cancer Hospital

Haikou, Hainan, China

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Qingdao Central Hospital

Qingdao, Shandong, China

Zhejiang Provincial Tongde Hospital

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT05892354


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