Changes in Inflammatory Response After Immunonutrition Compared to Standard Nutritional Support in Colorectal Cancer Tissue - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in expression of inflammatory cytokines in tumor tissue samples obtained prior and after intervention.
研究概览
简要总结
It is Randomized Controlled Trial, in which investigators will estimate the impact of the use of immunonutrition support compared to standard nutritional support in the preoperative period in patients with colorectal cancer.
详细描述
The first choice of treatment in colorectal cancer is surgery. Nutritional support in form of oral nutritional supplements (ONS) in the preoperative period is widely accepted in reducing the incidence of perioperative complications and immunonutrition is generally recommended. However, there is little clinical data regarding the impact of such treatment on a tumor biology.
Investigators want to perform Randomized Controlled Trial to explore the impact of the use of immunonutrition in relation to standard nutritional support in the preoperative period on alternating the expression of inflammatory response cytokines expression and leukocytes infiltration in tumor tissue in patients operated for colorectal cancer.
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
- None
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
- •Diagnosis of colon cancer during preoperative colonoscopy confirmed by histopathological examination.
排除标准
- •emergency/urgent operation
- •active infection
- •inflammatory bowel diseases in history
- •other systemic immune disorders
- •the necessity of preoperative neoadjuvant treatment (radiotherapy or chemotherapy)
- •metastatic disease, or local infiltration of cancer which was described as T4 stage in preoperative CT scan
- •patients who were not able to intake at least 85% of administrated ONS doses
结局指标
主要结局
Change in expression of inflammatory cytokines in tumor tissue samples obtained prior and after intervention.
时间窗: up to 13 months
Expression of following inflammatory cytokines will be measured: Tumor necrosis factor (TNF-α), Interleukin 8 or chemokine (C-X-C motif) ligand (CXCL8), stromal cell-derived factor 1 (SDF-1a), Chemokine (C-X-C motif) ligand 6 (CXCL6), Chemokine (C-X-C motif) ligand 2 (CXCL2), myeloperoxidase (MPO), Chemokine (C-X-C motif) ligand 1 (CXCL1) prior and after intervention. Measurements of cytokines' tissue concentration will be presented in pg/100ug of total protein.
次要结局
- Changes in tissue neutrophil infiltration after preoperative nutritional intervention in tumor tissue samples obtained prior and after intervention.(up to 13 months)
研究者
Michał Pędziwiatr
Prof., MD, PhD
Jagiellonian University