Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer
2017年4月20日 更新者：Jaw-Yuan Wang, MD, PhD、Kaohsiung Medical University Chung-Ho Memorial Hospital
Combination of Arginine, Glutamine, and Omega-3 Fatty Acid Supplements for Perioperative Enteral Nutrition in Surgical Patients With Gastric Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)
The survey is a phase IV, prospective randomized clinical trial to determine whether an immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional status and reduce postoperative infection and surgery-induced immune suppression in patients with gastric cancer or GIST undergoing major surgery in a single medical center.
研究概览
详细说明
Primary Objective:
The primary end points:
To evaluate the effect of immunomodulating diets on the postoperative inflammatory response: including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α).
- Secondary Objectives:
(1). Biochemistry parameters: glucose,blood urine nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, sodium, and leukocyte count.
(2). Nutritional status: albumin, prealbumin, BMI (3). Adverse events (4). Clinical outcomes: postoperative complications, time to first bowel action and length of hospital stay after surgery.
Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach 15 patients at least in each.
Plan of the Study:
- This is a randomized, comparative, double blinded study in 2 arms.
- Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.
- Duration of Treatment: Treatment was administered before curative surgery for gastric adenocarcinoma or gastric GIST, and postoperative day 5-14 or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.
研究类型
介入性
注册 (实际的)
34
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kaohsiung、台湾、807
- Chung-Ho Memorial Hospital, Kaohsiung Medical University:
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age between 20-85 years old
- Histologically proven primary gastric cancer or GIST.
- Patients was planning to receive elective curative gastric surgery, such as partial gastrectomy, subtotal gastrectomy, proximal gastrectomy, total gastrectomy, etc.
- Patient is able to understand the requirements of the study and written informed consent was obtained from each subject.
Exclusion Criteria:
- They were less than 20 years or over 85 years old
- Hepatic dysfunction or bile stasis (serum total bilirubin >2.5 mg/dL)
- Renal dysfunction (serum creatinine >1.5 mg/dL), or required hemodialysis
- Cardiac dysfunction (NYHA functional class >III, or stroke history)
- Severe hypoalbuminemia (albumin <2.5 g/dL)
- Karnofsky performance status less than 60
- Overweight (body mass index [BMI] >30 kg/m2)
- Exhibited drug abuse or chronic alcoholism
- Had life-threatening disease, or underwent emergent surgery
- With infection or bowel obstruction
- Pregnant or lactating
- Had received chemotherapy within 14 days of the initiation of the trial
- Had received immunosuppressive therapy or had immunological diseases recently
- Had already participated in another clinical study with an investigational drug or an investigational medical device within a month of the initiation or during the study
- Hypersensitive to casein, fish oil, soybean, or corn oil
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：immunomodulating nutrients enriched diet
Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST.
On postoperative day 3, enteral nutrition (EN) was initiated with 5% glucose in water at a rate of 20 mL/h.
On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet.
From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the interventional diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited.
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其他名称：
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有源比较器：standard diet
Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the standard diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST.
On postoperative day 3, EN was initiated with 5% glucose in water at a rate of 20 mL/h.
On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the interventional diet.
From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the standard diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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immunomodulating effects
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were employed to assess inflammatory processes.
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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blood glucose
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood urine nitrogen
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood aspartate aminotransferase (AST) in U/L
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood alanine aminotransferase (ALT) in U/L
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood triglycerides (TG) in mg/dL
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood cholesterol in mg/mL
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood low-density lipoprotein (LDL) in mg/mL
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood high-density lipoprotein (HDL) in mg/mL
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood sodium (Na) mEq/L
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood leukocyte count cells/μL
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood albumin in g/dL
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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blood prealbumin in mg/dL
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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body mass index (BMI) in kg/m^2
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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postoperative complications
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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postoperative complications that related to surgery
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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time to first bowel action
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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interval of surgery to first bowel action (hours)
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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length of hospital stay after surgery
大体时间：at discharge from the hospital or 14 days after surgery, whichever occurred first
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length of hospital stay after surgery (days)
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at discharge from the hospital or 14 days after surgery, whichever occurred first
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Jaw-Yuan Wang, PhD、Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年6月1日
初级完成 (实际的)
2016年6月1日
研究完成 (实际的)
2016年9月1日
研究注册日期
首次提交
2017年4月5日
首先提交符合 QC 标准的
2017年4月20日
首次发布 (实际的)
2017年4月21日
研究记录更新
最后更新发布 (实际的)
2017年4月21日
上次提交的符合 QC 标准的更新
2017年4月20日
最后验证
2017年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.