Clinical Trial

Immunonutrition for Prehabilitation of Patients With Colorectal Cancer Before Surgery

Study acronym: IMNUTPREH-CRC
Completed
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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.
Trial Details
NCT Number NCT07653737
Lead Sponsor Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions Colorectal Cancer, Nutrition Aspect of Cancer
Enrollment 56 participants
Start Date 2024-01-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-17