Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05892354

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

Led by First Affiliated Hospital of Guangxi Medical University · Updated on 2024-08-07

190

Participants Needed

20

Research Sites

198 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Guangxi Medical University

Lead Sponsor

G

Guangdong Provincial People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or non-pregnant female patients aged 18 to 70 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III)
  • Newly diagnosed stage III-IVa nasopharyngeal carcinoma without metastasis
  • Adequate organ function including blood counts, liver, kidney, coagulation, and cardiac enzymes
  • Ability to comply with study visits, treatment, and laboratory tests
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • History of using Oral Impact® or ENSURE® within one month before enrollment
  • Allergy or intolerance to Oral Impact®, ENSURE®, or related chemotherapy drugs
  • Poor blood sugar control in diabetic patients
  • Autoimmune diseases
  • Active infections
  • Previous radiation or anti-tumor treatments
  • History of other malignant tumors
  • Presence of oral mucositis at study start
  • Malnutrition at study start
  • Inability to eat required food amounts or need for parenteral/enteral nutrition at baseline
  • Inability to eat soft solid foods at baseline
  • HIV or active hepatitis B/C infection
  • Participation in other intervention clinical trials within one month
  • Other serious illnesses, mental health conditions, or social/family factors affecting safety or data collection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 20 locations

1

Fujian Provincial Hospital

Fuzhou, Fujian, China, 350000

Actively Recruiting

2

Fujian Cancer Hospital

Fuzhou, Fujian, China, 350014

Actively Recruiting

3

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China, 510060

Actively Recruiting

4

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China, 510070

Actively Recruiting

5

Huizhou Municipal Central Hospital

Huizhou, Guangdong, China, 516001

Actively Recruiting

6

The Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China, 541001

Actively Recruiting

7

Liuzhou Workers Hospital

Liuzhou, Guangxi, China, 545025

Actively Recruiting

8

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China, 530000

Actively Recruiting

9

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China, 543002

Actively Recruiting

10

First People People's Hospital of Yulin City

Yulin, Guangxi, China, 537001

Actively Recruiting

11

Red Cross Hospital of Yulin City

Yulin, Guangxi, China, 537006

Actively Recruiting

12

Huizhou Municipal Central Hospital

Haikou, Hainan, China, 570208

Actively Recruiting

13

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China, 570311

Actively Recruiting

14

Hainan Cancer Hospital

Haikou, Hainan, China, 570314

Actively Recruiting

15

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330000

Actively Recruiting

16

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330209

Actively Recruiting

17

Qingdao Central Hospital

Qingdao, Shandong, China, 266044

Actively Recruiting

18

Zhejiang Provincial Tongde Hospital

Hangzhou, Zhejiang, China, 310012

Actively Recruiting

19

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China, 310014

Actively Recruiting

20

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

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Research Team

Z

Zhen Meng, M.D

CONTACT

Y

Yating Qin, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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