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Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy

NCT07531563 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2026-04-15

No results posted yet for this study

Summary

This clinical trial aims to evaluate whether oral supplementation with a hydrolyzed whey protein formula ("TeYiShu") can reduce the incidence of severe radiation-induced oral mucositis and improve prealbumin levels in patients undergoing radiotherapy for head and neck squamous cell carcinoma (HNSCC). The study will compare the protein supplement to an isocaloric placebo without protein, maintaining equal caloric intake across groups. Participants will receive either the protein supplement or placebo daily throughout the course of radiotherapy. The primary outcomes are the incidence of grade ≥3 oral mucositis, assessed using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria, and changes in serum prealbumin levels. Secondary outcomes include the time to onset and resolution of mucositis, nutritional status changes, adverse events, and quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Cancer Module (EORTC QLQ-H\&N35).

Conditions

  • Head & Neck Cancer

Interventions

DIETARY_SUPPLEMENT

Hydrolyzed Whey Protein Oral Supplement

A liquid oral supplement containing hydrolyzed whey protein, administered daily during the entire course of radiotherapy. Each 200mL bottle provides approximately 24g of protein. The supplement is given in addition to standard nutritional counseling and baseline dietary support. The aim is to achieve a total protein intake of 2.0 ± 0.2 g/kg/day, in accordance with cancer nutrition guidelines. This intervention is designed to evaluate whether high-dose protein supplementation reduces the incidence and severity of radiation-induced oral mucositis and improves serum prealbumin levels in head and neck cancer patients.

DIETARY_SUPPLEMENT

Control

An isocaloric placebo oral supplement that matches the protein supplement in appearance, taste, volume (200mL), and frequency of administration. The placebo contains no protein or amino acids and provides equivalent caloric content through carbohydrates. It is administered daily throughout the course of radiotherapy, alongside standard nutritional counseling and baseline dietary support (20-25 kcal/kg/day and 1-1.2 g protein/kg/day). This intervention is used to control for the effects of additional caloric intake, isolating the impact of supplemental protein on clinical outcomes.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Ye Zhang, MD · Chinese Academy of Medical Sciences, National Cancer Center, Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07531563 on ClinicalTrials.gov