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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immuno-group | Experimental | The immuno-group will consist of patients who, as part of preoperative nutritional support, used immunonutrition ONS (2x Impact OralĀ® Nestle, Switzerland per day) for 2 weeks before surgery. |
|
| Control-group | Sham Comparator | The control group will consist of patients who, as part of preoperative nutritional support, used standard ONS (3x Fortimel Compact ProteinĀ® Nutricia, United Kingdom per day) for 2 weeks before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunonutrition | Dietary Supplement | Impact OralĀ® Nestle, Switzerland |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 13 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MichaÅ PÄdziwiatr, Prof. | Jagiellonian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Department of General Surgery, Jagiellonian University Medical College | Krakow | MaÅopolska | 30-688 | Poland |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000093702 | Immunonutrition Diet |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomized 2-arm controlled trial
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| Standard Oral Nutritional Support | Dietary Supplement | Fortimel Compact ProteinĀ® Nutricia, United Kingdom |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |