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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210902001

Enrollment

100

Registered

2021-09-02

Start date

2021-10-14

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-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 Neck Neoplasms Neoplasms, Neck Neck Neoplasm Neoplasm, Neck Cancer of Neck Neck Cancers

Interventions

Immunonutrition (IN) will be given diary, start 1 week before radiotherapy and continue during radiotherapy treatment until end of treatment.,Patients in this arm will be treated as the standard of ca

Experimental Dietary Supplement,No Intervention No treatment

Immunonutrition,Control

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Oral mucositis At the end of treatment Clinical examination	—

Secondary

Measure	Time frame
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	—

Countries

Thailand

Contacts

Public ContactPooriwat Muangwong

Faculty of Medicine, Chiang Mai University

pooriwat.m@cmu.ac.th6653935450

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026