An interventional study of Immunonutrition and Standard Oral Nutritional Support in Colon Cancer and Nutrition Aspect of Cancer, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Jagiellonian University · Not applicable, Interventional, and Supportive care
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.
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 30 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
The immuno-group will consist of patients who, as part of preoperative nutritional support, used immunonutrition ONS (2x Impact Oral® Nestle, Switzerland per day) for 2 weeks before surgery.
Dietary Supplement: Immunonutrition
The control group will consist of patients who, as part of preoperative nutritional support, used standard ONS (3x Fortimel Compact Protein® Nutricia, United Kingdom per day) for 2 weeks before surgery.
Dietary Supplement: Standard Oral Nutritional Support
Impact Oral® Nestle, Switzerland
Also known as: Immunonutrition Oral Nutritional Support
Fortimel Compact Protein® Nutricia, United Kingdom
Change in expression of inflammatory cytokines in tumor tissue samples obtained prior and after intervention.
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.
Time frame: up to 13 months
Changes in tissue neutrophil infiltration after preoperative nutritional intervention in tumor tissue samples obtained prior and after intervention.
Neutrophil infiltration will be assessed by counting the number of neutrophils per 10 large microscopic fields.
Time frame: up to 13 months
Plan to share: No
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Jagiellonian University