Colorectal Cancer, Nutrition Aspect of Cancer
Conditions
Keywords
postsurgical complications, sarcopenia, immunonutrition
Brief 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.
Interventions
DIETARY_SUPPLEMENTOral nutritional supplement with inmmunonutrition
Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid)
DIETARY_SUPPLEMENTStandard oral nutritional supplement
Oral nutritional supplement with high protein content but not enriched with arginine or any other component of immunonutrition
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-surgical complications | From surgery until 90 days post-hospital discharge | 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
| Measure | Time frame | Description |
|---|---|---|
| Weight (Kg) | From preoperative evaluation until 90 days after hospital discharge | Weight of the patient at each visit |
| Height (cm) | From preoperative evaluation until 90 days after hospital discharge | Height of the patient at each visit |
| BMI (Kg/m2) | From preoperative evaluation until 90 days after hospital discharge | Body mass index of the patients calculated using weight and height |
| Weight loss (%) | From preoperative evaluation until 90 days after hospital discharge | Percentage of weight loss from the preoperative baseline weight of the patient |
| MUST (malnutrition universal screening tool) score. | From preoperative evaluation until 90 days after hospital discharge | Nutritional assessment by anthropometric methods including weight, weight loss, height, and body mass index, are used to give the MUST (malnutrition universal screening tool) score. |
| Muscle mass - SMMI (cm2/m2) | From preoperative evaluation until 90 days adter surgery | Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments. |
| Psoas muscle index (cm2/m2) | From preoperative evaluation until 90 days after hospital discharge | Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area and index, periabdominal musculature, and fat compartments. |
| Subcutaneous fat tissue (cm2) | From preoperative evaluation until 90 days after hospital discharge | Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments. |
| Visceral fat tissue (cm2) | From preoperative evaluation until 90 days after hospital discharge | Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments. |
Countries
Spain
Outcome results
None listed