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Completed
NCT07653737
Immunonutrition for Prehabilitation of Patients With Colorectal Cancer Before Surgery
Conditions: Colorectal Cancer, Nutrition Aspect of Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 56
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Location: Hospital Universitario Ramón y Cajal Madrid Madrid
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07653737). StuddyBuddy aggregates publicly available trial information.