Nutritional Management During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma Has an Impact on Immunonutritional Status and Therapeutic Phase Toxicity and Prognostic Effects
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Decreased proportion of immune cell subsets
研究概览
简要总结
Nasopharyngeal carcinoma (NPC) is a malignant tumor that develops in the nasopharyngeal mucosal epithelium. Due to the disease itself and the impact of anti-tumor therapy, malnutrition has become a common clinical complication in patients with NPC, among which NPC patients receiving concurrent chemoradiotherapy are one of the groups with the highest incidence of malnutrition, and malnutrition seriously affects the prognosis of NPC patients. Nutritional management throughout the course has a positive impact on the prognosis and life management of NPC patients. As an immune-enhancing oral nutritional preparation, it is helpful to maintain the weight and immune function of patients with nasopharyngeal carcinoma during concurrent chemoradiotherapy, reduce the degree of treatment-related side effects during concurrent chemoradiotherapy for nasopharyngeal carcinoma, and delay the occurrence of acute side effects. The purpose of this study was to investigate the effect of rapid rapid rapid improvement of patients' immune status during concurrent chemoradiotherapy, and to further evaluate its impact on patients' weight, prognosis, treatment-related toxic side effects, and quality of life. In this study, 109 patients with nasopharyngeal carcinoma who received concurrent chemoradiotherapy in our hospital are planned to be included, and all patients in this group will be given oral tachyphin at a standard dose from the first day of radiotherapy. The nutritional immune status of the patient was assessed at different points during the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients with nasopharyngeal carcinoma confirmed by histopathology;2.Clinical stage stage II-IVa,Concurrent chemoradiotherapy is included in the definitive treatment regimen;3.Age ≥ 18 years, male or female;4.PG-SGA score of 0-8 before radiotherapy;5.KPS score ≥ 60 or ECOG score ≤3;6.Nutritional supplementation can be given by mouth or enterally;7.Patients sign a formal informed consent form to indicate that they understand that this study complies with hospital policies;8.Serum hemoglobin ≥ 90 g/L, platelet ≥ 100×109/L, absolute neutrophil count ≥ 1.5×109/L;9.serum creatinine ≤1.25 times ULN or creatinine clearance ≥60 mL/min;10.Serum bilirubin ≤ 1.5-fold ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5-fold ULN, and alkaline phosphatase ≤ 5-fold ULN.
排除标准
- •1.Have a second primary tumor;2.Those who do not receive concurrent chemoradiotherapy;3.Comorbid diabetes mellitus, or history of severe endocrine and metabolic diseases;4.Those who are allergic to oral nutritional meal replacements.
结局指标
主要结局
Decreased proportion of immune cell subsets
时间窗: 2 weeks
The proportion of immune cell subsets that decline during chemoradiotherapy, including CD3, CD4, CD8
Decreased proportion of immune cell subsets
时间窗: 2 weeks
The proportion of immune cell subsets that decline during chemoradiotherapy, including CD3, CD4, CD8
次要结局
- Change in the patient's weight(2 weeks)
- Disease Free Survival(3 Years)
- Change in the patient's weight(2 weeks)
- Disease Free Survival(3 Years)