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

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.

Conditions

• Locally Advanced Nasopharyngeal Carcinoma

Interventions

DIETARY_SUPPLEMENT

Enteral immunonutrition

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

DIETARY_SUPPLEMENT

Standard 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).

Sponsors & Collaborators

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Zhejiang Provincial People's Hospital

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Fujian Provincial Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  collaborator OTHER

• Qingdao Central Hospital

  collaborator OTHER

• Huizhou Municipal Central Hospital

  collaborator OTHER

• Haikou People's Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Hainan Medical University

  collaborator OTHER

• Zhejiang Provincial Tongde Hospital

  collaborator OTHER

• Guilin Medical University, China

  collaborator OTHER

• Liuzhou Workers' Hospital

  collaborator OTHER_GOV

• Wuzhou Red Cross Hospital

  collaborator OTHER

• Red Cross Hospital of Yulin City

  collaborator OTHER

• First People's Hospital of Yulin

  collaborator OTHER

• Hainan Cancer Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  lead OTHER

Principal Investigators

• Min Kang, M.D · Department of Radiation Oncology, The First Affiliated Hospital of Guangxi Medical University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-12

Primary Completion

2025-04-30

Completion

2027-04-01

Countries

• China

Study Locations