Effects Of Standard And/Or Glutamine Dipeptide And/Or Omega-3 Fatty Ascid-Supplemented Parenteral Nutrition On Neutrophil Functions, Interleukin-8 Level And Length Of Stay-A Double Blind,Controlled, Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- neutrophil functions
研究概览
简要总结
Hypercatabolism and immune suppression are frequently seen in patients with malignancy. Preoperative nutritional state is an important factor in determining surgical and postoperative complications because the preoperative nutritional status affects the postoperative nutritional state, immunity and inflammatory response. In these patients, standard parenteral nutrition may not be sufficient to maintain the immunity and provide positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor- alfa. There is a report which showed that glutamine dipeptide supplemented parenteral nutrition improved the cellular and humoral immune functions. The investigators aimed to evaluate the effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid supplemented parenteral nutrition on the neutrophil functions and postoperative course of patients with colorectal cancer.
详细描述
Purpose Hypercatabolism and immune suppression are frequently seen in patients with malignancy.Preoperative nutritional state is an important factor in determining surgical and postoperative complications because the preoperative nutritional status affects the postoperative nutritional state, immunity and inflammatory response.In these patients, standard parenteral nutrition may not be sufficient to maintain the immunity and provide positive or stabilized nitrogen balance. Preoperative and perioperative supplementation with immune-enhancing enteral nutrition has been reported to increase total lymphocytes and T lymphocytes and decrease circulating levels of interleukin 6 and tumor necrosis factor- alfa.There is a report which showed that glutamine dipeptide supplemented parenteral nutrition improved the cellular and humoral immune functions. The investigators aimed to evaluate the effect of postoperative glutamine-dipeptide and/or omega 3 fatty acid supplemented parenteral nutrition on the neutrophil functions and postoperative course of patients with colorectal cancer.
Condition Intervention Phase Malnutrition Colorectal Cancer Dietary Supplement: Immunonutrition Phase 4
Study Type: Interventional Study Design: Prevention, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, N/A
Official Title: Effects Of Standard And/Or Glutamine Dipeptide And/Or Omega-3 Fatty Ascid-Supplemented Parenteral Nutrition On Neutrophil Functions, Interleukin-8 Level And Length Of Stay-A Double Blind,Controlled, Randomized Study
Primary Outcome Measure: Title: neutrophil functions Time Frame: perioperative,postoperative third and seventh days for change in first seven days of hospital stay Description: For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colorectal cancer patients who were included study were between 50 and 70 years old
排除标准
- •preoperatively suffered from serious comorbid chronic disease and received chemotherapy and radiotherapy
- •immunosuppressive and /or immunomodulator drugs in last 6 months
研究组 & 干预措施
Control (standard) (Kabiven)
an isocaloric and iso-nitrogenous standard parenteral nutrition (Kabiven)
干预措施: Standard (Kabiven) (Dietary Supplement)
Standard parenteral-glutamine (S-D)
alanine-glutamine (aln-gln) (Dipeptiven) supplemented parenteral nutrition (S-D group, n=8),
干预措施: Standard-Glutamine (Dietary Supplement)
Standard-Omega-3 fatty acid (S-O)
Omega-3 fatty acid (Omegaven) supplemented parenteral nutrition (S-O group, n=8)
干预措施: Standard-Omega 3 fatty acid (Dietary Supplement)
Standard-glutamine-omega 3 (S-D-O)
ala-gln and omega 3 fatty ascid supplemented parenteral nutrition (S-D-O group, n=10).
干预措施: Standard-glutamine-omega 3 (Dietary Supplement)
结局指标
主要结局
neutrophil functions
时间窗: perioperative,postoperative third and seventh days for change in first seven days of hospital stay
For comparison of four different nutrition on neutrophil functions in first seven days of hospital stays.
次要结局
- Length of stay(Length of stay (participants will be followed for the duration of hospital stay) for colorectal cancer patients which are eligable for study study from january 2007 to january 2008 in one year period.)
研究者
Nuh Zafer Cantürk
Professor in Surgical Oncology and head of Nutrition Team
Kocaeli University