Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- postoperative outcomes
研究概览
简要总结
The goal of this clinical trial is to compare the effect of perioperative immunonutrition supplement in gynecologic cancer patients. The main questions it aims to answer are:
- is there any difference in the nutritional outcomes and functional outcomes between intervention and conventional groups?
- is there any difference in the post-surgical outcomes between intervention and conventional groups?
Participants (intervention) will be provided the immunonutrition supplement before and after operation.
Researchers will compare intervention group with conventional group to see if there is any difference in postoperative outcomes.
详细描述
The clinical trial aims to determine the effectiveness of perioperative IMN intervention on postoperative outcomes among GC patients under Enhanced Recovery after Surgery (ERAS) setting. Patients will prescribed with immunonutrition supplement before and 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Those who diagnosed with GC
- •Candidates for elective operation treatments
排除标准
- •Those are involved gastrointestinal tract (complication)
- •Those are diagnosed with GC (metastasis)
- •Allergy to milk/soy/whey protein
- •Participate in other intervention study
研究组 & 干预措施
intervention
Participants will be given 2 servings immunonutrition daily for five (5) days before tentative elective surgery. ERAS protocol will implement and continued 2 servings of immunonutrition for post-operative seven (7) days.
干预措施: Immunonutrition oral nutrition supplementation (Dietary Supplement)
conventional
Participants will be on usual diet intake before tentative elective surgery. ERAS protocol will implement and will be prescribed 2 servings of polymeric formula daily only if unable to finish 75% of the diet served in ward.
结局指标
主要结局
postoperative outcomes
时间窗: 1 months
length of hospitalization
body composition
时间窗: 1 month
body composition analyzer; weight in kg; fat free mass in kg; fat mass in kg; muscle mass in kg; height in meter
daily energy and protein intake
时间窗: 1 month
24-hours diet recall
immunoglobulin level
时间窗: 1 month
Concentration of immunoglobulin G; Concentration of immunoglobulin A; Concentration of immunoglobulin M
C-reactive protein
时间窗: 1 month
Concentration of C-reactive protein
次要结局
- stress level(1 month)
- Functional status(1 month)
研究者
ChiouYi Ho
Principal Investigator
Universiti Putra Malaysia