Effect of Enteral Immunonutrition on Immune, Inflammatory Markers and Nutritional Status in Patients Undergoing Gastrectomy for Gastric Cancer：a Randomized Double Blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 主要终点
- Change from baseline serum level of immune cytokines to postoperative day 5
研究概览
简要总结
Enteral immunonutrition (EIN) has been gaining increasing attention, but data of its immune and anti-inflammatory function in patients undergoing gastrectomy for gastric cancer are poorly investigated. The aim of this study was to assess the effect of EIN on immune function, inflammation response and nutrition status when compared to standard enteral nutrition (SEN).
The investigators believe that the proportion of cluster of differentiation 4 T-cells(CD4＋T-cells), cluster of differentiation 3 T-cells(CD3＋T-cells) and the counts of CD4＋ / cluster of differentiation 8 T-cells (CD8＋), immunoglobulin G(IgG), immunoglobulin M(IgM), and immunoglobulin A (IgA) were larger in EIN group, while the level of WBC, CRP and TNF-α were lower and nutritional status was similar.
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
- Double (Participant, Investigator)
盲法说明
Eligible patients were randomly assigned in equal numbers to undergo SEN or EIN according to a computer-generated randomization list managed by a dietary nurse not involved in the study. The study was double-blind: SEN and EIN feeds were identical in color and type of container, so treatment assignments were not revealed to patients or to any staff members.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 80 years
- •with histologically diagnosed cancer of stomach
- •candidates for elective subtotal or total gastrectomy
排除标准
- •pregnant or lactating woman,
- •diagnoses of mental diseases
- •resent severe concomitant diseases (chronic cardiopulmonary disease, chronic renal failure, etc.)
- •known allergies to nutrition formula or component
- •drug intolerance
- •known immunodeficiency or autoimmune diseases
研究组 & 干预措施
EIN group
Enteral formula including not only basic energy components, but also immune components such as omega-3 fatty acids, glutamine (Gln), arginine (Arg), and nucleotide.
干预措施: enteral immunonutrition (Dietary Supplement)
SEN group
Enteral formula including only basic energy components.
干预措施: enteral immunonutrition (Dietary Supplement)
结局指标
主要结局
Change from baseline serum level of immune cytokines to postoperative day 5
时间窗: baseline and postoperative day 5
levels of IgA, IgG and IgM in g/L,
Change from baseline serum concentration of immune markers to postoperative day 5
时间窗: baseline, postoperative day 5(POD 5)
percentage of CD3＋ T cell of serum
Change from baseline serum level of immune markers to postoperative day 5
时间窗: baseline, postoperative day 5(POD 5)
count of CD4＋/CD8＋
次要结局
- changes among baseline, postoperative day 1, 3 and 5 serum concentration of inflammatory markers(baseline, postoperative day 1, 3, and 5)
- Change among baseline, postoperative day 3 and 5 serum nutritional markers(baseline,postoperative day 3 and 5)
研究者
Yong Zhou
associate chief physician
West China Hospital