Upper GI CancerIMNUTPREH-UGICNCT07884214
Immunonutrition for Surgical Prehabilitation of Patients With Upper GI Cancer
A study testing Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid) and Standart of care in people with Upper GI Cancer, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper GI Cancer
- What is being tested?
- Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid) and Standart of care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to 1 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for upper GI cancer surgery
Who cannot join
- 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)
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- HIV infection
- Pregnancy
- Intestinal obstruction
- Active uncontrolled infection
- Dementia, advanced degenerative neurological disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nutritional Therapy in the Surgical Prehabilitation of Patients With Esophageal, Gastric, and Pancreatic Cancer to Assess the Reduction of Postoperative Complications and the Maintenance of Muscle Mass.
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.
Read the 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.
- Conditions
- Upper GI Cancer
- Being tested
- Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid), Standart of care
- Keywords
- immunonutrition, upper GI cancer, prehabilitation, surgery, malnutrition, oral nutritional supplements
- Medical subject headings
- Gastrointestinal Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid)Dietary supplement
Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid)
Standart of careDietary supplement
Standard oral nutritional supplements if needed guided by usual practice hospital protocol.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard oral nutritional supplements Receives: Dietary Supplement: Standart of care |
| Immunonutrition | Experimental | Oral nutritional supplements with immunonutrition Receives: Dietary Supplement: Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From surgery until 90 days post-hospital discharge
Secondary outcomes (9)
Weight (Kg)
Weight of the patient at each visit
Measured: From preoperative evaluation until 90 days after hospital discharge
Height
Height of the patient at each visit
Measured: From preoperative evaluation until 90 days after hospital discharge
Body mass index (BMI)
Body mass index of the patients calculated using weight and height
Measured: From preoperative evaluation until 90 days after hospital discharge
Weight loss (%)
Percentage of weight loss from the preoperative baseline weight of the patient
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From preoperative evaluation until 90 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper GI CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Ignacio Botella, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884214
- Sponsor's protocol ID
- PI212/23
- Other IDs
- SENPE-212/23
- Acronym
- IMNUTPREH-UGIC
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No