Integrative Parenteral Nutrition in Hospitalized, Malnourished, Hypophagic Cancer Patients With Contraindication to Enteral Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Phase angle
研究概览
简要总结
Although it is demonstrated that nutritional support can improve clinical outcomes, the literature shows that approximately 50% of cancer patients are not able to meet their estimated energy requirements. Recent clinical studies suggest that a supplementary support for parenteral nutrition (PN) could significantly help to improve the nutritional status of malnourished cancer patients.
International guidelines recommend the use of PN in malnourished, hypophagic, non-surgical cancer patients if enteral nutrition is not feasible and in patients affected by severe iatrogenic gastrointestinal complications and in whom inadequate food intake is anticipated for more than 7 days. However, there are no studies on the effects of integrative PN in hospitalized, malnourished, hypophagic, non-surgical cancer patients.
Recent studies have reported on the validity of bioelectrical impedance vector analysis in monitoring the body composition of patients receiving nutritional support. Particularly, phase angle proved to be a superior prognostic marker than other nutritional screening tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnosis of cancer (head-neck, lung, gastrointestinal, pancreas, biliary tract, haematology).
- •Nutritional Risk Screening 2002 score ≥
- •Expected duration of parenteral nutrition ≥7 days
- •Availability to planned measurements
- •Contraindication to enteral nutrition support
- •Written informed consent
排除标准
- •Age < 18 years
- •Ongoing artificial nutrition before hospitalization
- •Eastern Cooperative Oncology Group performance status >2
研究组 & 干预措施
Parenteral nutrition
Patients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements
干预措施: Parenteral nutrition (Dietary Supplement)
结局指标
主要结局
Phase angle
时间窗: 7 days
Change in phase angle (a specific body composition parameter assessed by bioelectrical impedance vector analysis) after 7 days of nutritional support
次要结局
- body weight(7 days)
- body mass index(7 days)
- Number of participants with treatment-related adverse events as assessed by biochemistry(7 days)
- Handgrip strength(7 days)
研究者
Riccardo Caccialanza
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia