Changes in Inflammatory Response After Immunonutrition Compared to Standard Nutritional Support in Colorectal Cancer Tissue - Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Colon Cancer
- Sponsor
- Jagiellonian University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in expression of inflammatory cytokines in tumor tissue samples obtained prior and after intervention.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Michał Pędziwiatr
Prof., MD, PhD
Jagiellonian University
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of colon cancer during preoperative colonoscopy confirmed by histopathological examination.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in expression of inflammatory cytokines in tumor tissue samples obtained prior and after intervention.
Time Frame: 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.
Secondary Outcomes
- Changes in tissue neutrophil infiltration after preoperative nutritional intervention in tumor tissue samples obtained prior and after intervention.(up to 13 months)