Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head & Neck Cancer | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Dietary Supplement | — | UNRESOLVED |
| Hydrolyzed Whey Protein Oral Supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Arm: Protein Supplementation Group
- description
- Participants in this arm will receive an oral hydrolyzed whey protein supplement ("TeYiShu") daily, starting from the first day of radiotherapy and continuing until the end of radiotherapy. The supplement provides approximately 24 g of protein per 200 mL bottle, in addition to standard nutritional counseling and baseline nutrition support (20-25 kcal/kg/day and 1-1.2 g protein/kg/day). The total protein intake target for this group is 2.0 ± 0.2 g/kg/day, in accordance with Chinese Society of Clinical Oncology (CSCO) guidelines. The intervention aims to evaluate the effect of high-protein oral supplementation on radiation-induced oral mucositis and nutritional status in patients with head and neck cancer.
- interventionNames
- Dietary Supplement: Hydrolyzed Whey Protein Oral Supplement
- type
- PLACEBO_COMPARATOR
- label
- Control Arm: Placebo Group
- description
- Participants in this arm will receive an isocaloric placebo supplement that matches the experimental product in appearance, taste, volume (200mL), and administration frequency but contains no protein or amino acids. The placebo provides equivalent caloric content via carbohydrates. Participants will also receive standard nutritional counseling and baseline nutrition support (20-25 kcal/kg/day and 1-1.2 g protein/kg/day). This arm is designed to isolate the effect of additional protein supplementation by ensuring total energy intake is balanced across both groups.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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) * Inborn errors of amino acid metabolism * Cognitive impairment, psychiatric illness, or other factors affecting compliance or informed consent
References
Publications (0)
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