Clinical trial · Interventional
Changes in Inflammatory Response After Immunonutrition Compared to Standard Nutrition in Colorectal Cancer Tissue
Changes in Inflammatory Response After Immunonutrition Compared to Standard Nutritional Support in Colorectal Cancer Tissue - Randomized Controlled Trial
NCT04732442CI-TRIAL-00049745completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Nutrition Aspect of Cancer | Colon Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunonutrition | Dietary Supplement | — | UNRESOLVED |
| Standard Oral Nutritional Support | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immuno-group
- description
- 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.
- interventionNames
- Dietary Supplement: Immunonutrition
- type
- SHAM_COMPARATOR
- label
- Control-group
- description
- 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.
- interventionNames
- Dietary Supplement: Standard Oral Nutritional Support
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.