The Impact of Immune Nutrition on Nutritional and Immune Status of Head and Neck Cancer Patients During Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 主要终点
- Severity of oral mucositis measured by CTCAE v4.0 (Grades 0-4)
研究概览
简要总结
Head and neck cancer (HNC) is one of the most common types of malignant tumors, often leading to malnutrition due to its complex anatomical location near many functional organs. Radiotherapy, an essential treatment modality for HNC, can exacerbate malnutrition, potentially causing radiotherapy failure. Both domestic and international guidelines advocate early nutritional intervention for HNC patients at risk of malnutrition; however, specific recommendations on the type of nutritional treatment are lacking. Immunonutrition has shown promise in regulating the immune microenvironment, enhancing immune response, and reducing radiotherapy side effects compared to conventional nutritional interventions. However, there is a lack of studies focusing on immunonutritional therapy during the radiotherapy process for HNC in China. Therefore, this study aims to investigate the effects of immunonutrition on nutritional status, immune function, and quality of life (QoL) in head and neck cancer (HNC) patients undergoing radiotherapy.
This prospective interventional study enrolled 48 head and neck cancer (HNC) patients scheduled to undergo radiotherapy (with or without concurrent chemotherapy). All participants received an immunonutrition formula supplemented with arginine, ω-3 fatty acids, and nucleotides. Throughout the radiotherapy course, certified dietitians and oncology nurses provided standardized nutritional guidance based on a five-step nutritional management protocol. Primary outcomes included:Radiotherapy-related adverse events (e.g., mucositis, dysphagia) assessed at four time points during radiotherapy (weeks 1, 3, 5, and 7) using CTCAE v4.0 criteria;Longitudinal changes in nutritional status (serum albumin, BMI), immune-related biomarkers , and quality of life were assessed at baseline, mid-radiotherapy (week 4), and post-treatment (week 7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients must be histologically or cytologically confirmed to have head and neck cancer (HNC).
- •Scheduled for radiotherapy with or without concurrent chemotherapy.
- •Willingness to sign informed consent voluntarily.
- •Aged between 18 and 75 years old.
- •Karnofsky Performance Status (KPS) score ≥
- •Hematological and biochemical parameters within the following ranges:
- •White blood cell count (WBC) ≥3.5×10^9/L
- •Hemoglobin (Hb) ≥90 g/L
- •Platelet count (PLT) ≥100×10^9/L
- •Serum albumin (ALB) ≥30 g/L
- •Total bilirubin ≤1.5 times the upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 - times ULN
- •Life expectancy of at least 6 months.
- •No severe malnutrition at baseline (e.g., body mass index [BMI] >18.5 kg/m²).
排除标准
- •Prior history of radiation therapy or biological therapy targeting the head and neck region.
- •History of other malignant tumors in the past 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ.
- •Severe systemic diseases, such as uncontrolled diabetes mellitus, severe cardiovascular disease, or chronic renal failure.
- •Pregnancy or lactation.
- •Drug or alcohol abuse.
- •Participation in other clinical trials within the last 3 months.
- •Known allergies or contraindications to the nutritional formulations used in this study.
- •Mental disorders or cognitive impairments that may affect compliance with the study protocol.
- •Inability to tolerate oral nutritional supplements (ONS).
- •Any condition deemed by the investigator to potentially interfere with the study objectives or participant safety
结局指标
主要结局
Severity of oral mucositis measured by CTCAE v4.0 (Grades 0-4)
时间窗: Assessed weekly during radiotherapy at weeks 1, 3, 5, and 7 of treatment
The grades of oral mucositis were measured and recorded by our professional nutritionists at four time periods during radiotherapy. The classification standard of oral mucositis was based on CTCAE v4.0 (Grade 0: asymptomatic; Grade I: Erythema appears on the oral mucosa, accompanied by pain, but it does not affect eating; Grade II: Erythema and ulcers appear on the oral mucosa, and solid food can be consumed; Grade III: Severe erythema and ulcers appear on the oral mucosa, and solid food cannot be consumed; Grade IV: Ulcers have fused into patches, with necrosis, and the patient is unable to eat)
次要结局
- Change in body weight (kg) from baseline(at baseline, mid-radiotherapy (week 4), and post-treatment (week 7))
- Change in Body Mass Index (BMI, kg/m²) from baseline(at baseline, mid-radiotherapy (week 4), and post-treatment (week 7))
- Change in serum albumin concentration (g/dL) from baseline(at baseline, mid-radiotherapy (week 4), and post-treatment (week 7))
研究者
Tao Zhang
Chief of Radiotherapy department
First Affiliated Hospital of Chongqing Medical University