Colon Cancer, Nutrition Aspect of Cancer
Conditions
Keywords
immunonutrition, colon cancer, inflammatory response, perioperative care, randomized controlled trial
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.
Interventions
DIETARY_SUPPLEMENTImmunonutrition
Impact Oral® Nestle, Switzerland
DIETARY_SUPPLEMENTStandard Oral Nutritional Support
Fortimel Compact Protein® Nutricia, United Kingdom
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized 2-arm controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in expression of inflammatory cytokines in tumor tissue samples obtained prior and after intervention. | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in tissue neutrophil infiltration after preoperative nutritional intervention in tumor tissue samples obtained prior and after intervention. | up to 13 months | Neutrophil infiltration will be assessed by counting the number of neutrophils per 10 large microscopic fields. |
Countries
Poland
Outcome results
None listed