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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).
This study is a randomized, controlled clinical trial designed to evaluate the effect of oral hydrolyzed whey protein supplementation on radiation-induced oral mucositis and nutritional status in patients with head and neck squamous cell carcinoma (HNSCC) receiving radiotherapy. Participants will be assigned to receive either a hydrolyzed whey protein formula ("TeYiShu") or an isocaloric placebo without protein during the course of radiotherapy, in addition to standard nutritional counseling and baseline nutrition support.
The primary objectives are to determine whether protein supplementation reduces the incidence of Grade 3 or higher radiation-induced oral mucositis, assessed according to the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria, and improves serum prealbumin levels from baseline to the end of radiotherapy. Secondary objectives include evaluation of time to onset and resolution of oral mucositis, changes in body weight and other indicators of nutritional status, adverse events, and changes in quality of life assessed 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).
The study aims to clarify whether high-protein oral nutritional supplementation can improve treatment tolerance and supportive care outcomes in patients undergoing radiotherapy for head and neck cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm: Protein Supplementation Group | Experimental | 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. |
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| Control Arm: Placebo Group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrolyzed Whey Protein Oral Supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to end of radiotherapy (approximately 6-8 weeks) |
| 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. | From the start of radiotherapy to 3 months post-radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From onset of mucositis to recovery or 3 months post-radiotherapy |
| Change in Body Weight During Radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gulidanna Shayan, MD | Contact | +8618500369703 | gldanna@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ye Zhang, MD | Chinese Academy of Medical Sciences, National Cancer Center, Cancer Hospital | Principal Investigator |
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| Control | Dietary Supplement | 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. |
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The difference in body weight from baseline to the end of radiotherapy, used as a proxy for nutritional status and treatment tolerance. |
| Baseline to end of radiotherapy (approximately 6-8 weeks) |
| 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. | Baseline, during radiotherapy, and at end of radiotherapy |
| 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. | Baseline, during radiotherapy, and at end of radiotherapy |
| Incidence of Adverse Events | Occurrence of treatment-related adverse events, including gastrointestinal symptoms (nausea, vomiting, diarrhea, and abdominal pain) and other acute toxicities, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. | From start of radiotherapy through 3 months post-radiotherapy |
| Incidence of Serious Adverse Events | Serious adverse events are defined as events that result in death, are life-threatening, require inpatient hospitalization or prolongation of existing hospitalization, result in persistent or significant disability/incapacity, or are otherwise medically important. | From start of radiotherapy through 3 months post-radiotherapy |
| Opioid Usage for Oral Pain Control | Total cumulative dose of opioid analgesics used by participants during the study period to control oral pain due to mucositis, recorded and analyzed as an indicator of symptom severity. | From start of radiotherapy to end of treatment (approximately 6-8 weeks) |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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