Immunonutrition Supplement for Reducing Acute Oral Mucositis in Head and Neck Cancer Radiotherapy

Phase 2

Completed

• Conditions: on-nasopharyngeal head and neck cancer; Neoplasms, Head and Neck; Head, Neck Neoplasms; Head and Neck Neoplasm; Cancer of Head and Neck; Head and Neck Cancer; Cancer of the Head and Neck; Neoplasms, Head; Head Neoplasm; Neoplasm, Head

• Registration Number: TCTR20210902001
• Lead Sponsor: Division of Radiotherapy and Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-02
• Study Completion: 2023-05-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Age range between 18 - 70-year-old
2.Histologically confirmed squamous cell carcinoma of head and neck.
3.Locally advanced head and neck cancer planning to treat with concurrent chemoradiotherapy for definitive or postoperative setting.
4.No previous radiotherapy in head and neck area.
5.Good performance status with ECOG 0-1.
6.Laboratory tests are in the normal ranges.
7.The participant or legal representative provides the written informed consent for the study.

Exclusion Criteria

1.Histological subtypes other than squamous cell carcinoma (e.g., Adenocarcinoma, small cell carcinoma).
2.Has metastatic disease or locoregional recurrence.
3.Receive immune-enhancing nutrition product prior to the randomization within 30 days.
4.Allergy to immune-enhancing nutrition ingredients used in the study.
5.Active autoimmune disease(s) that require medication within 2 years.
6.Diabetes Mellitus, renal disease, liver disease and/or other disease that limits some nutrition or calorie intake.
7.Known disease or condition that would interfere with the cooperation of the study.
8.Pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral mucositis At the end of treatment Clinical examination

Secondary Outcome Measures

Name	Time	Method
Dematitis At the end of treatment Clinical examination,Nutritional status During the treatment weight, BMI, albumin,Immunity During the treatment Lab test,Inflammation During the treatment Lab test