Effect of Postoperative Family Nutrition Mode on Weight/BMI of Patients With Esophageal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 23
- 主要终点
- Percentage of 5% body weight loss on Day 30
研究概览
简要总结
This clinical trial is designed to be a multi-center prospective observational study which shall compare the effect of different postoperative home nutrition modes on recent nutritional index (weight/BMI) of patients with esophageal cancer and recent outcomes. Different postoperative home nutrition modes adopted in this study includes oral natural diet, oral nutrition supplement and tube feeding.
详细描述
STUDY BACKGROUND Esophageal cancer is a common cancer in China and due to its influence on diet intake, patients with esophageal cancer are often combined with nutrition deficiency, which causes relatively high nutrition risk to treatment. Studies conducted by Martin et al showed that the degree of body weight loss in patients with malignancy is related to BMI level and prognosis. The patients with severe body weight loss and low BMI have poor prognosis, especially for patients with esophageal cancer.
At present, perioperative nutrition support for patients with esophageal cancer has been recognized and has been recommended as routine in 2017 NCCN guideline. How to implement good home nutrition within one month after patient discharge and recover nutrition index as soon as possible has become a focus for esophageal surgeon.
Many clinical trials have already investigated enteral nutrition support approach during anti-cancer treatment period in patients with malignancy. However, only a few clinical trials are good designed. Therefore the investigators hope to via this multi-center prospective observational study to provide evidence for this question.
OBJECTIVES:
- To explore the relationship between postoperative home nutrition support treatment approach and nutritional status of patients with esophageal cancer;
- To explore the relationship between postoperative home nutrition support treatment approach and recent prognosis in patients with esophageal cancer;
- To promote the standardized application of postoperative home nutrition support treatment for patients with esophageal cancer.\
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age below 80 years old;
- •Esophageal cancer;
- •Radical surgery;
- •Normal gastrointestinal function
排除标准
- •Patients with diabetes and poor blood glucose control;
- •Patients with severe postoperative complications;
- •Patients who can't tolerate lactose;
- •Patients who decline inclusion and follow-ups
结局指标
主要结局
Percentage of 5% body weight loss on Day 30
时间窗: Day 30 after discharge
Percentage of 5% body weight loss on Day 30 compared to the body weight at discharge
次要结局
- Complications of home enteral nutrition support(Day30)
- Completion ratio of different nutrition support approaches(Day 30 after discharge)
- Delay and interruption ratio of adjuvant treatment(Day 30 and Day 90)
- Re-hospitalization ratio(Day 90)
- Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale(Day30 and Day 90)
研究者
Ke-Neng Chen, MD, PhD, FRCS
Doctor
Peking University Cancer Hospital & Institute