Immunonutrition for Prehabilitation of Patients With Colorectal Cancer Before Surgery (IMNUTPREH-CRC)

Study of Nutritional Management for Prehabilitation: Surgical and Nutritional Outcomes in Patients With Colorectal Cancer Treated With Oral Nutritional Supplements With and Without Immunonutrition.

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Nutrition Aspect of Cancer
• Intervention / Treatment: Dietary supplement: Standard oral nutritional supplement; Dietary supplement: Oral nutritional supplement with inmmunonutrition

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28034
      • Hospital Universitario Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standard oral nutritional supplements	Dietary supplement: Standard oral nutritional supplement; Oral nutritional supplement with high protein content but not enriched with arginine or any other component of immunonutrition
Experimental: Immunonutrition; Oral nutritional supplements with immunonutrition	Dietary supplement: Oral nutritional supplement with inmmunonutrition; Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-surgical complications	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).	From surgery until 90 days post-hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight (Kg)	Weight of the patient at each visit	From preoperative evaluation until 90 days after hospital discharge
Height (cm)	Height of the patient at each visit	From preoperative evaluation until 90 days after hospital discharge
BMI (Kg/m2)	Body mass index of the patients calculated using weight and height	From preoperative evaluation until 90 days after hospital discharge
Weight loss (%)	Percentage of weight loss from the preoperative baseline weight of the patient	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 universal screening tool) score.	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, periabdominal musculature, and fat compartments.	From preoperative evaluation until 90 days adter surgery
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.	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, periabdominal musculature, and fat compartments.	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, periabdominal musculature, and fat compartments.	From preoperative evaluation until 90 days after hospital discharge

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: sarcopenia; immunonutrition; postsurgical complications
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Colorectal Neoplasms; Sarcopenia; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: PI118/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy/ethical restrictions, as they contain information that could compromise the privacy of research participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No