An interventional study of Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid) and Standart of care in Upper GI Cancer, sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Not applicable, Interventional, and Treatment
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.
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.
795 studies on the registry are indexed under Gastrointestinal Neoplasms; 235 are open to participants now.
This study's planned enrollment of 110 is above the median of 60 across 580 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal is the lead sponsor of 83 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Standard oral nutritional supplements
Dietary Supplement: Standart of care
Oral nutritional supplements with immunonutrition
Dietary Supplement: Oral 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)
Standard oral nutritional supplements if needed guided by usual practice hospital protocol.
Post-surgical complications
Complications classified as general and post-surgical; severity assessed using the Clavien-Dindo classification and global burden with the ComprehensiveComplication Index (CCI).
Time frame: From surgery until 90 days post-hospital discharge
Weight (Kg)
Weight of the patient at each visit
Time frame: From preoperative evaluation until 90 days after hospital discharge
Height
Height of the patient at each visit
Time frame: From preoperative evaluation until 90 days after hospital discharge
Body mass index (BMI)
Body mass index of the patients calculated using weight and height
Time frame: From preoperative evaluation until 90 days after hospital discharge
Weight loss (%)
Percentage of weight loss from the preoperative baseline weight of the patient
Time frame: From preoperative evaluation until 90 days after hospital discharge
MUST (malnutrition universal screening tool) score.
Nutritional assessment by anthropometric methods including weight, weight loss, height, and body mass index, are used to give the MUST (malnutrition universalscreening tool) score.
Time frame: From preoperative evaluation until 90 days after hospital discharge
Muscle mass - SMMI (cm2/m2)
Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominalmusculature, and fat compartments.
Time frame: From preoperative evaluation until 90 days after hospital discharge
Psoas muscle index (cm2/m2)
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.
Time frame: From preoperative evaluation until 90 days after hospital discharge
Subcutaneous fat tissue (cm2)
Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominalmusculature, and fat compartments.
Time frame: From preoperative evaluation until 90 days after hospital discharge
Visceral fat tissue (cm2)
Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominalmusculature, and fat compartments.
Time frame: From preoperative evaluation until 90 days after hospital discharge
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.
Of 165 non-industry interventional studies with no phase under Gastrointestinal Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 71. This study's planned 23 months is below that.
Counting every sponsor, half of 175 studies reached it within 32 months; a quarter within 16 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal