Upper GI Cancer
Conditions
Keywords
immunonutrition, upper GI cancer, prehabilitation, surgery, malnutrition, oral nutritional supplements
Brief summary
Perioperative immunonutrition has been proposed as a strategy to modulate the inflammatory response and improve outcomes after upper GI 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 upper GI cancer (gastric, esophageal, pancreatic), evaluating postoperativecomplications and changes in body composition.
Detailed description
A randomized clinical trial in two groups of 55 patients with esophageal, gastric, or pancreatic cancer undergoing surgical treatment with or without neoadjuvant therapy. The intervention group will receive nutritional therapy with preoperative oral nutritional immunonutrient supplements for at least 15 days before surgery, and postoperative nutritional supplements with an immunonutrient formulation to be maintained for at least 3 months following surgery. The control group will consist of standard clinical practice following the center's established ERAS (Enhanced Recovery After Surgery / RICA) protocol, whereby only patients at risk of malnutrition through nutritional screening receive standard preoperative supplements, and postoperative supplementation is administered during hospital admission in cases of decreased oral intake. Postoperative complications will be assessed using the Clavien-Dindo classification, and muscle mass will be measured via abdominal CT scans at the L3 level. All patients will undergo ultrasound for the measurement of the rectus femoris/quadriceps femoris and abdominal fat mass, as well as bioelectrical impedance analysis (BIA). Serum and plasma aliquots will be sent to the center's biobank for the determination of circulating muscle-related biomarkers.
Interventions
DIETARY_SUPPLEMENTOral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid)
Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid)
DIETARY_SUPPLEMENTStandart of care
Standard oral nutritional supplements if needed guided by usual practice hospital protocol.
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients eligible for upper GI cancer surgery
Exclusion criteria
* Non-surgical upper GI 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 classified as general and post-surgical; severity assessed using the Clavien-Dindo classification and global burden with the ComprehensiveComplication 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 | From preoperative evaluation until 90 days after hospital discharge | Height of the patient at each visit |
| Body mass index (BMI) | 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 universalscreening tool) score. |
| Muscle mass - SMMI (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, periabdominalmusculature, 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, periabdominalmusculature, 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, periabdominalmusculature, and fat compartments. |
Countries
Spain
Outcome results
None listed