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).
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
PG-SGA score ≥8 (indicating severe nutritional risk)
Use of non-guideline-recommended oral care during radiotherapy
Use of other protein supplementation products during radiotherapy
Known allergy to components of the study product
Parallel
Hydrolyzed Whey Protein Oral Supplement
Dietary supplementA 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.
Control
Dietary supplementAn 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.
Change in Serum Prealbumin Levels
Change in serum prealbumin (PAB) levels from baseline to the end of radiotherapy. Blood samples will be collected before the initiation of radiotherapy and at the completion of treatment. The difference will be calculated to assess the nutritional effect of the protein supplement.
Incidence of Grade ≥3 Radiation-Induced Oral Mucositis
The number and proportion of participants who develop Grade 3 or higher acute oral mucositis during or within 3 months after radiotherapy, assessed according to the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria.
Time to Resolution of Grade ≥3 Oral Mucositis
The number of days from the onset of Grade ≥3 radiation-induced oral mucositis to its resolution to Grade 1 or lower, based on RTOG criteria.
Change in Body Weight During Radiotherapy
The difference in body weight from baseline to the end of radiotherapy, used as a proxy for nutritional status and treatment tolerance.
Change in Quality of Life Score: EORTC QLQ-C30
Change in patient-reported quality of life, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), from baseline to the end of radiotherapy. Scores are linearly transformed to a 0 to 100 scale. For the global health status and functional scales, higher scores indicate better quality of life or functioning; for the symptom scales/items, higher scores indicate greater symptom burden.
Change in Head and Neck Cancer-Specific Quality of Life Score: EORTC QLQ-H&N35
Change in patient-reported head and neck cancer-specific quality of life, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck Cancer Module (EORTC QLQ-H\&N35), from baseline to the end of radiotherapy. Scores are linearly transformed to a 0 to 100 scale, with higher scores indicating worse symptoms or problems.
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