NCT06059560招募中不适用
An Open, Real-world Study of the Effects of Perioperative Intensive Nutritional Management on Short-term Quality of Life and Long-term Life Outcomes in Patients With Multiple Cancers
First Hospital of China Medical University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Survival index
研究概览
简要总结
To evaluate the nutritional status of patients with different types of tumors by continuous nutritional intervention and follow-up intervention in the perioperative period,and the impact on progression-free survival/survival and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •① Age ≥18 years old, <80 years old, male or female; ② The patient signed the informed consent and volunteered to participate in the study; ③ Patients with malignant tumors (laryngeal cancer, esophageal cancer, lung cancer, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer) evaluated by clinical stage II to IV; ④ Patients undergoing tumor surgery; ⑤ Patients with NRS 2002 score ≥ 3 after management risk screening; ⑥ Basic reading and communication skills; ⑦ Have the ability to act; Patients with a life expectancy greater than 6 months;
排除标准
- •① Acute onset of chronic disease; ② Pregnant or lactating women; ③ Patients with contraindications and no tumor surgery; (4) Patients with malignant tumors (laryngeal cancer, esophageal cancer, lung cancer, stomach cancer, colorectal cancer, liver cancer, pancreatic cancer) were confirmed by pathology and/or cytology after surgery; ⑤ Combined with cognitive dysfunction, mental disorder, consciousness disorder or unwillingness to cooperate; ⑥ Patients with severe gastrointestinal symptoms, liver and renal insufficiency (alanine aminotransferase ALT≥2 times the upper limit of normal value; Total bilirubin Tbil≥2 times the upper limit of normal value; Creatinine Cr≥2 times the upper limit of normal value); (7) Patients with two or more types of tumors; Long-term bed rest, hemiplegia or coma; ⑨ Severe dysfunction of liver, kidney and other organs; ⑩ Allergy or intolerance to nutrients or their main components (such as lactose or galactose, etc.).
结局指标
主要结局
Survival index
时间窗: 3 years
DFS/OS
次要结局
- Quality of life index(3years)
研究者
Kai Li
Deputy Director of surgical Oncology
First Hospital of China Medical University
研究点 (1)
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