NCT07531563Not yet recruiting
Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy
Effect of Oral Protein Hydrolysate Supplementation on Radiation-Induced Severe Oral Mucositis and Prealbumin Levels in Patients With Head and Neck Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 504 (estimated)
- First submitted
- 31 Mar 2026
- Start date
- Jul 2026
- Primary completion date
- Jul 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Head and neck cancer
- NCT number
- NCT07531563
What you commit to
- Study type: Interventional
- Planned participants: 504
- From Jul 2026 to the primary completion date, Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of non-guideline-recommended oral care during radiotherapy
- Use of other protein supplementation products during radiotherapy
Other illness
- Known allergy to components of the study product
- Acute or chronic renal insufficiency
- Severe hepatic impairment
- Congestive heart failure requiring fluid restriction
- Gastrointestinal disorders affecting amino acid absorption (e.g., atrophic gastritis, bowel obstruction, inflammatory bowel disease)
- Conditions increasing aspiration risk (e.g., abdominal compartment syndrome, gastric emptying disorders)
- Cognitive impairment, psychiatric illness, or other factors affecting compliance or informed consent
Other
- PG-SGA score ≥8 (indicating severe nutritional risk)
- Inborn errors of amino acid metabolism
Who the study is looking for
- Age 18-75 years
- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- No distant metastases (M0 stage)
- Planned to receive curative or postoperative radiotherapy (with or without concurrent therapy) with a mean oral cavity dose ≥20 Gy
- Adequate nutritional intake via oral or nasogastric route
- Willingness to follow NCCN/MASCC guidelines for oral care during radiotherapy
- Signed written informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.