Clinical trial · Interventional
Immunonutrition for Prehabilitation of Patients With Colorectal Cancer Before Surgery
Study of Nutritional Management for Prehabilitation: Surgical and Nutritional Outcomes in Patients With Colorectal Cancer Treated With Oral Nutritional Supplements With and Without Immunonutrition.
- 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)
Perioperative immunonutrition has been proposed as a strategy to modulate the inflammatory response and improve outcomes after colorectal surgery. However, clinical evidence is heterogeneous, and there are few studies that integrate morbidity outcomes with objective measures of body composition using computed tomography (CT). The objective was to compare immunonutrition versus standard enteral supplementation in surgically treated patients with colorectal cancer, evaluating postoperative complications and changes in body composition. This study was designed as a 1:1 randomized, open-label, two-arm clinical trial: CONTROL group (standard nutritional oral supplements) and IMMUNONUTRITION (immunonutrition oral supplements). Patients were prescribed these daily oral nutritional supplements at least five days before surgery. PRIMARY OUTCOME: Post-surgical complications were classified as general and post-surgical; severity was assessed using the Clavien-Dindo classification and global burden with the Comprehensive Complication Index (CCI). SECONDARY OUTCOMES: Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments. Intragroup changes and the percentage of change between groups were compared. An exploratory analysis was performed in patients with sarcopenia defined by SMMI cut-off points. HYPOTHESIS: It is expected that preoperative immunotherapy may result in less post-surgical complications and better body composition.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Nutrition Aspect of Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral nutritional supplement with inmmunonutrition | Dietary Supplement | — | UNRESOLVED |
| Standard oral nutritional supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Standard oral nutritional supplements
- interventionNames
- Dietary Supplement: Standard oral nutritional supplement
- type
- EXPERIMENTAL
- label
- Immunonutrition
- description
- Oral nutritional supplements with immunonutrition
- interventionNames
- Dietary Supplement: Oral nutritional supplement with inmmunonutrition
Primary outcomes (1)
- measure
- Post-surgical complications
- timeFrame
- From surgery until 90 days post-hospital discharge
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients eligible for colorectal cancer surgery Exclusion Criteria: * Non-surgical colorectal cancer * End-stage liver o kidney disease * Emergency surgery * Previous nutritional supplements * Hypersensitivity to arginine, omega-3, or nucleotides * Inability for oral nutrition (dysphagia, esophageal/pyloric stenosis) * HIV infection * Pregnancy * Intestinal obstruction * Active uncontrolled infection * Dementia, advanced degenerative neurological disease.
References
Publications (0)
Data not yet available