Effect of Oral Protein Hydrolysate Supplementation on Radiation-Induced Severe Oral Mucositis and Prealbumin Levels in Patients With Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 504
- 主要终点
- Change in Serum Prealbumin Levels
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Arm: Protein Supplementation Group
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.
干预措施: Hydrolyzed Whey Protein Oral Supplement (Dietary Supplement)
Control Arm: Placebo Group
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.
干预措施: Control (Dietary Supplement)
结局指标
主要结局
Change in Serum Prealbumin Levels
时间窗: Baseline to end of radiotherapy (approximately 6-8 weeks)
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
时间窗: From the start of radiotherapy to 3 months post-radiotherapy
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.
次要结局
- Time to Resolution of Grade ≥3 Oral Mucositis(From onset of mucositis to recovery or 3 months post-radiotherapy)
- Change in Body Weight During Radiotherapy(Baseline to end of radiotherapy (approximately 6-8 weeks))
- Change in Quality of Life Score: EORTC QLQ-C30(Baseline, during radiotherapy, and at end of radiotherapy)
- Change in Head and Neck Cancer-Specific Quality of Life Score: EORTC QLQ-H&N35(Baseline, during radiotherapy, and at end of radiotherapy)
- Incidence of Adverse Events(From start of radiotherapy through 3 months post-radiotherapy)
- Incidence of Serious Adverse Events(From start of radiotherapy through 3 months post-radiotherapy)
- Opioid Usage for Oral Pain Control(From start of radiotherapy to end of treatment (approximately 6-8 weeks))