NCT02664974已完成3 期
Home Enteral Nutrition in Malnourished Patients With Gastrointestinal Cancer: A Multicenter Randomized Clinical Trial
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano4 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2008年12月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 4
- 主要终点
- Maintenance of body weight
研究概览
简要总结
Phase III, medical, multicentric, controlled, open label, two-parallel groups, randomized, clinical trial.
The aim of this study is to evaluate the efficacy of home enteral nutrition on the nutritional status, the quality of life and tolerance to chemotherapy, in malnourished patients who undergo major gastrointestinal surgery for malignancy (oesophagus, stomach, pancreas, biliary tract). Patients were randomized to receive either home enteral nutrition (HEN, treatment group) or nutritional counselling (control group).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender with age higher than 18 years.
- •Documented cancer of the gastrointestinal tract: oesophagus, stomach, pancreas, biliary tract
- •Candidate for major elective surgery.
- •Preoperative nutritional risk score ≥ 3
- •Written informed consent.
排除标准
- •Age < 18 years
- •Karnofsky index < 60
- •Renal insufficiency (Ongoing haemodialysis or plasma creatinine > 3 mg/dL)
- •Respiratory insufficiency
- •Child-Pugh class C
- •Short Bowel Syndrome
- •Pregnancy
- •Emergency operation
- •Foreign residence or residence in Italian region with no regulation designed for home artificial nutrition
结局指标
主要结局
Maintenance of body weight
时间窗: 2 months
Evaluated by weight change after discharge
次要结局
- Improvement of tolerance to chemotherapy(6 months)
- Improvement of quality of life(2 months)
研究者
研究点 (4)
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