Early IntraVenous Administration of Nutritional Support (IVANS) in Metastatic Gastric, Cancer Patients at Nutritional Risk Undergoing First-line Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Combined endpoint - overall survival and weight maintenance
研究概览
简要总结
The present trial will be conducted to verify if early supplemental parenteral nutrition in combination with nutritional counseling improves survival and the feasibility of chemotherapy, in addition to nutritional status, body composition, functional status and quality of life in treatment-naïve patients with metastatic gastric cancer at nutritional risk undergoing first-line chemotherapy.
详细描述
Although it is known that nutritional support can improve clinical outcomes, the literature shows that only around 50% of cancer patients are able to satisfy estimated protein-calorie requirements. It is also emerging a strong correlation between nutritional status, particularly body composition, and adherence to active treatment. International guidelines suggest that parenteral nutrition (PN) is recommended in malnourished, hypophagic cancer patients suffering from gastrointestinal complications or with expected prolonged inadequate food intake, when enteral nutrition is not feasible. Although recent trials suggest that supplemental PN (SPN) could help to improve the nutritional status of malnourished cancer patients, there are no studies on the clinical effects of early SPN in cancer patients at nutritional risk receiving first-line chemotherapy.
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
- •histologically confirmed diagnosis of metastatic gastric and gastroesophageal cancer;
- •no previous chemotherapy for metastatic disease;
- •indication for a first-line chemotherapy with a combination of 2 drugs including platinum derivatives (plus Trastuzumab if HER2+) to be used by investigator's choice within the framework of good clinical practice and in agreement with current Italian Association of Medical Oncology guidelines;
- •measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST);
- •presence of nutritional risk (Nutritional Risk Screening 2002 score ≥3);
- •availability of permanent venous access (Port, Groshong, PICC);
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
- •availability of a home parenteral nutrition service to continue nutritional plan as scheduled;
- •signed informed consent.
排除标准
- •age <18 years
- •ECOG performance status >2
- •indication to complete artificial nutrition support (totally compromised spontaneous food-intake)
- •contraindication to parenteral nutrition (abnormal glucose and electrolytes control, hyper-triglyceridemia, impaired hemodynamic control and fluid retention)
- •availability of jejunostomy for nutritional purposes
- •ongoing home artificial nutrition
- •unfeasible home parenteral nutrition for social/familial reasons
- •absence of caregivers
- •patients refusal
结局指标
主要结局
Combined endpoint - overall survival and weight maintenance
时间窗: 12 months
A combined endpoint consisting of overall and/or absence of unintentional weight loss \>10% of the weight recorded at enrollment
次要结局
- Eligibility to second-line chemotherapy(12 months)
- Overall survival(12 months)
- Patients requiring unplanned hospitalization(12 months)
- Total dose of chemotherapy administered(4 months)
- Change in handgrip strength(12 months)
- Change in self-perceived quality of life(12 months)
- Incidence of infections(12 months)
- Progression-Free Survival (PFS)(12 months)
- Change in body weight(12 months)
- Treatment-related moderate-severe adverse events as assessed by CTCAE v4.0(4 months)
- Objective response rate(4 months)
- Change in phase angle(12 months)
- Change in muscle mass(12 months)
- Abnormal values in safety laboratory variables(12 months)
研究者
Riccardo Caccialanza
Director - Clinical Nutrition and Dietetics Unit
Fondazione IRCCS Policlinico San Matteo di Pavia