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Immunonutrition for Prehabilitation of Patients With Colorectal Cancer Before Surgery
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Summary
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.
Official title: Study of Nutritional Management for Prehabilitation: Surgical and Nutritional Outcomes in Patients With Colorectal Cancer Treated With Oral Nutritional Supplements With and Without Immunonutrition.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2024-01-01
Completion Date
2026-03-31
Last Updated
2026-06-17
Healthy Volunteers
No
Interventions
Oral nutritional supplement with inmmunonutrition
Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid)
Standard oral nutritional supplement
Oral nutritional supplement with high protein content but not enriched with arginine or any other component of immunonutrition
Locations (1)
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain