Novel Immune-modulating Formula Versus Standard Formula for Malnourished Gastrointestinal Cancer Patients Undergoing Cancer Surgery: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in C-reactive protein
研究概览
简要总结
Malnutrition is a common feature in cancer patients and associated with worse outcomes especially increased risk of postoperative complications in patients undergoing surgery.
The European Society for Clinical Nutrition and Metabolism (ESPEN) recommends preoperative oral/enteral immunonutrition support to decrease risk of postoperative complications. However, the evidence comparing between immune formula and standard formula is still controversial. Numerous studies have indicated that curcumin is beneficial to the immune system. This study aimed to assess the effect of an immune formula which contains curcumin versus standard formula for malnourished gastrointestinal cancer patients undergoing cancer surgery.
A randomized controlled trial will be conducted on 40 malnourished gastrointestinal cancer patients who plan to undergo major cancer surgery. Patients in the intervention group will receive 2 sachets of immune formula per day (355.5 kcal and curcumin 25 mg per sachet) for 10-14 days and dietary counseling. Participants in the control group will receive 2 sachets of isocaloric standard formula per day for 10-14 days and dietary counseling. Anthropometry and biochemical parameters were measured in 3 periods (before intervention, two weeks after intervention in preoperative, and post-operative period). Postoperative complications were recorded until patient discharge from hospital for 30 days.
详细描述
Malnutrition is a common feature in cancer patients and associated with worse outcomes especially increased risk of postoperative complications in patients undergoing surgery.
The European Society for Clinical Nutrition and Metabolism (ESPEN) recommends preoperative oral/enteral immunonutrition support to decrease risk of postoperative complications especially in malnourished patients undergoing major abdominal surgery. Numerous studies have indicated that curcumin is beneficial to the immune system. This study aimed to assess the effect of an immune formula which contains curcumin versus standard formula for malnourished gastrointestinal cancer patients undergoing cancer surgery.
A randomized controlled trial will be conducted on 40 malnourished gastrointestinal cancer patients who plan to undergo major cancer surgery. Patients in the intervention group will receive 2 sachets of immune formula per day (355.5 kcal and curcumin 25 mg per sachet) for 10-14 days and dietary counseling. Participants in the control group will receive 2 sachets of isocaloric standard formula per day for 10-14 days and dietary counseling.
Body mass index (BMI), body composition, mid-arm muscle circumference (MAMC), hand grip strength, food intake, pre-albumin, C-reactive protein (CRP), Interleukin-6 (IL-6), and Tumor necrosis factor alpha (TNF-alpha) are measured at the day before and the day after having all of oral nutrition supplements. Parameters are re-measured within 5-7 days after operation along with fasting blood sugar, insulin and HOMAR-IR. Postoperative complications are assessed with Clavien-Dindo classification on the last day in the hospital. Re-admit rates are recorded until 30 days after discharge.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
- The same sachet, taste, and appearance for both formula
- Care provider and outcome assessor will be blinded for study arm of the participants.
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
- •Participants who were malnourished gastrointestinal cancer patients and plan to treatment with surgery
- •Participant aged ≥18 years
排除标准
- •Participants who weren't willing to participate in a clinical trial.
- •Participants who were pregnant or lactating
- •Participants who were enteral feeding intolerance such as gastrointestinal obstruction
- •Participants who receive jejunal feeding
- •Participant has been taking an immune formula prior to the baseline visit.
- •Participants who were allergic to components of the study formula such as milk,soy.
研究组 & 干预措施
Intervention group
Participants receive 2 packages of immune formula per day for 10-14 days + dietary counseling
干预措施: Oral Nutrition supplement (Dietary Supplement)
Control group
Participants receive 2 packages of standard formula per day for 10-14 days + dietary counseling
结局指标
主要结局
Change in C-reactive protein
时间窗: Baseline,Study day 10-14, After surgery day 5-7
C-reactive protein in mg/L
Change in Tumor necrosis factor alpha (TNF-α)
时间窗: Baseline,Study day 10-14, After surgery day 5-7
Tumor necrosis factor alpha in pg/ml
Change in interleukin-6 (IL-6)
时间窗: Baseline,Study day 10-14, After surgery day 5-7
Interleukin-6 in pg/ml
次要结局
- Change in Prealbumin(Baseline,Study day 10-14, After surgery day 5-7)
- Mid-upper arm circumference(Baseline,Study day 10-14, After surgery day 5-7)
- Rate of re-admission within 30 days(30 day after discharge)
- Fasting blood glucose(After surgery day 5-7)
- Insulin (Homa IR)(After surgery day 5-7)
- Gastrointestinal tolerance(Baseline,Study day 10-14)
- BIA(Baseline,Study day 10-14, After surgery day 5-7)
- Handgrip strength(Baseline,Study day 10-14, After surgery day 5-7)
- Complication during hospitalized stay(Hospital stay)
- Rate of death during hospitalized stay(Hospital stay)