ImmunoNutrition and Colorectal Adenocarcinoma Surgery: a Randomized Study. INCAS Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Primary Outcome Measure - Number of patients with grade 2 or higher post-operative complications
研究概览
简要总结
Compared to upper gastrointestinal (GI) malignancies, CRC patients generally present with satisfactory nutritional status at surgery and malnutrition is typically present in advanced stages of CRC. Therefore, in the latter surgery may not be offered with curative intent. Based on the current evidence, the role of OIN appears to be consolidated for malnourished patients undergoing surgery for gastrointestinal cancer. Regarding not malnourished patients, there is still no clear correlation between OIN and decrease in post-operative complications. Furthermore, whether OIN increases immune response within the tumour microenvironment is based on studies with poor number of patients.
详细描述
Randomized, controlled, open-label, single-centre study in patients candidate for elective curative surgery for colon-rectal cancer.
The study intervention consists of the oral nutritional supplementation enriched with immune-nutrients delivered before and after surgery in addition to standard dietary advice according to E.R.A.S. protocol.
All patients will follow low-fiber diet according to ERAS protocol during the study period. Patients assigned to the experimental arm will assume also Impact Oral®, an oral nutritional supplement with immune-nutrients (hyper-proteic formula), manufactured and commercialized by Nestlé Health Science S.p.a. It is a liquid drink packaged in a brick of 237 ml. Patients will assume Impact Oral® for 5 days before surgery and 5 day after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients aged ≥ 18 years or older;
- •histologically confirmed adenocarcinoma of colon or rectum;
- •Eligible for elective curative surgery with indication of colon and/or rectal resection in laparoscopy with mini-invasive technique;
- •eligible for ERAS protocol;
- •Written informed consent to the study participation according to the Local Ethic Committee requirements before any study procedure;
排除标准
- •colon or rectal resection for benign disease;
- •TNM Stage ≥4;
- •neoadjuvant radio and/or chemotherapy
- •ASA score > 3;
- •contraindications to oral nutrition (e.g. dysphagia, pyloric stenosis) or hypersensitivity to any ingredient of study product;
- •albuminemia < 3.0 g/l;
- •weight loss > 10% in the last 3-6 months;
- •BMI < 18.5 kg/m2;
- •pregnant or breastfeeding;
- •Not self-sufficient or with poor family compliance;
- •Congenital or acquired immunodeficiency;
- •Active uncontrolled pre-operative infections or other clinically relevant concomitant illness that preclude laparoscopic procedure;
- •Bowel obstruction or parenteral nutrition or gastric tube;
结局指标
主要结局
Primary Outcome Measure - Number of patients with grade 2 or higher post-operative complications
时间窗: within 30 days post-surgical intervention
Number of patients with grade 2 or higher post-operative complications according to Clavien-Dindo classification occurred within 30 days post-surgical intervention.
次要结局
- Secondary Outcome Measure - Hospital length of stay(From the day of surgery until discharge, assessed up to 7 days)
- Secondary Outcome Measure - Safety assessed according to CTCAE(From admission to discharge, assessed up to 42 days)
- Secondary Outcome Measure - Nutritional status before and after surgery(differences at day 1, 3, 5, 15 and 30 after surgery from T0 (7-10 days before surgery) will be calculated and compared between the two arms)
- Secondary Outcome Measure - 30-day mortality for any cause(30-day mortality for any cause)
- Secondary Outcome Measure - Inflammatory status before and after surgery(differences at day 1, 3, 5, 15 and 30 after surgery from T0 (7-10 days before surgery) will be calculated and compared between the two arms)
- Secondary Outcome Measure - Reoperation rate(within 30 days following the index surgery)
- Secondary Outcome Measure - Unplanned readmissions(within 30 days from discharge)