A Prospective, Randomized Controlled Open Research About the Impact of Nutritional Support on the Radiation Tolerance and Clinical Outcomes for Local Advanced Nasopharyngeal Carcinoma Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
The chemo-radiotherapy for the local advanced nasopharyngeal carcinoma patients will induce the mucosal ulcer and damage salivary glands. Consequently, it can disturb the nutrition conditions and clinical outcomes of patients. This research tries to evaluate the nutrition status at the baseline, before and after radiotherapy, during the follow-up by the body mass index, hematological indexes, immunological indexes, and nutrition questionnaires including PG-SGA and NRS 2002. Through the evaluation of two different nutritional interventions, the investigators aim to find an optimized assessment model and the best nutrition support patterns.
详细描述
All nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. At the beginning, the investigators assign patient to experimental and control groups randomly. Patients in experimental group received standard nutritional support by adding NUTRISON. Control patients will give conventional nutritional guidance. The investigators collected all the nutritional indexed at first visit, before and after radiotherapy, 1, 3, 6, 9, 12 months after radiotherapy. All these data will be set into statistical software to produce an optimized model for clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically conformed Initial nasopharyngeal carcinoma
- •Patients can feed through the mouth.
- •ECOG (Eastern Cooperative Oncology Group) : 0-
- •No history of chemo-radiotherapy, immuno-therapy or biotherapy.
- •Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
- •Informed consent signed.
排除标准
- •History of malignant tumors.
- •Any severe complications contraindicated chemotherapy or radiotherapy.
- •Medical history of central nervous system, cognitive or psychological diseases;
- •Pregnant or nursing women.
- •Patients with mental disease cannot complete the questionaire.
- •Patients refused the informed consent.
研究组 & 干预措施
Regular diet
Regular diet without other nutritional intervention.
Nutrition support
Nutrison was added to regular diet while the patients can be fed through mouth. Nutrison will replace regular diet by NG or PEG while the patients can not eat for serious oral mucositis.
干预措施: Nutrison (Dietary Supplement)
结局指标
主要结局
Overall survival
时间窗: 5 years
From the first treatment to the death of any causes
次要结局
- Progress free survival(5 years)