Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Change of Serum Prealbumin level
研究概览
简要总结
This study will evaluate the efficacy and safety of Impact Oral in Patients undergoing Surgery for Gastrointestinal Cancer, half of the participants will receive Impact Oral nutrition therapy, the other half will receive Enteral Nutrition Emulsion(TPF-T) therapy.
详细描述
The present protocol describes a randomized, active-controlled, open labelled study in which either IMPACT Oral or Enteral Nutrition Emulsion(TPF-T) will be given to surgical patients for 5 days before surgery and 7 days after surgery. Both of the study products include immunonutrition, but the nutrient proportion is different.
Prealbumin, C-reaction protein (CRP), Albumin，immunology parameters, the results of physical examination, vital signs, relevant nutrition- and safety-related laboratory parameters and the number, severity, seriousness, relatedness and outcome of Adverse Events (AEs) will be evaluated in this study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with upper or lower gastrointestinal cancer confirmed by histological method and scheduled for radical resection via open or laparoscopic surgery plus gastrointestinal reconstruction. Radiotherapy and/or Chemotherapy was not performed within 2 weeks before screening.
- •Age18-75 years old (include 18 and 75 years old).
- •Body Mass Index 18.5-28kg/m2 (include 18.5 and28kg/m2).
- •Life expectancy more than 3 months.
- •Plasma haemoglobin ≥ 90g/l.
- •Plasma albumin ≥2.5 g/dl.
- •No blood product infused within 1 week prior to screening.
- •Patients are informed for consent, and agreed to participate in the study and sign the informed consent.
排除标准
- •Severe concomitant clinical conditions that could jeopardize the trial performance and follow-up.
- •Past history of gastrointestinal surgery or other treatment of digestive tract, and affect the nutrient absorption
- •Female patient who is pregnant or lactating woman.
- •Patient undergoing minor gastrointestinal cancer surgery such as confirmatory biopsy or endoscopy. Patient that has endoscopic tumour resection is also excluded.
- •Patient is not allowed any oral or enteral intake in the pre-operative phase of the study.
- •Having participated in another interventional clinical trial including those related to nutritional support within 4 weeks prior to the patient enrollment.
- •Other malignancies in the last 5 years (except for successfully treated in situ basocellular skin and in situ cervical uterine tumours).
- •Patient who is not willing and not able to comply with scheduled visits and the requirements of the study protocol.
- •Planned chemotherapy, radiotherapy or immunotherapy during the first 7 days following the surgical tumour resection.
- •Patient with liver and kidney dysfunction (alanine aminotransferase ALT ≥ 2 times the upper limit of normal; total bilirubin TBIL ≥ 2 times the upper limit of normal; creatinine Cr ≥ 2 times the upper limit of normal).
- •Known to have diabetes or fasting blood glucose≥ 10mmol/L.
- •Known to have hyperthreosis or hypothyreosis
- •Patient currently treated with Omega-3 fatty acid-containing fat emulsion, glutamine, thymosin, hormone, thyroxine, growth hormone, anti-TNF biological.
- •Known to have allergic history to any component of the investigational product.
- •Uncontrolled psychological disease.
结局指标
主要结局
Change of Serum Prealbumin level
时间窗: Change measures at baseline and Day 8 after surgery
The change of serum prealbumin level on Day 8 after surgery compared with baseline (before study products treatment).
次要结局
- Change of Serum Prealbumin level(Change measures at baseline and Day -1(before surgery) and Day1, Day3 after surgery)
- Change of Interleukin-6 (IL-6)(Change measures at baseline, Day -1(before surgery), Day 1, 3, 8(after surgery))
- Change of CD4+/CD8+(Change measures at baseline, Day -1(before surgery), Day1, 3, 8(after surgery))
- Change of Albumin(Change measures at baseline, Day -1(before surgery),Day 1, 3, 8(after surgery))
- Change of C-reactive protein(Change measures at baseline, Day -1(before surgery),Day1, 3, 8(after surgery))
- Incidence of postoperative Infections(up to Day 8 after surgery)