Immunonutrition for Prehabilitation of Patients With Colorectal Cancer Before Surgery

NCT07653737 | Completed

• 1 other identifier: PI118/22
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Nutrition Aspect of Cancer

Keywords

postsurgical complications; sarcopenia; immunonutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Weight (Kg)

  From preoperative evaluation until 90 days after hospital discharge

• Height (cm)

  From preoperative evaluation until 90 days after hospital discharge

• BMI (Kg/m2)

  From preoperative evaluation until 90 days after hospital discharge

• Weight loss (%)

  From preoperative evaluation until 90 days after hospital discharge

• MUST (malnutrition universal screening tool) score.

  From preoperative evaluation until 90 days after hospital discharge

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard oral nutritional supplements

Dietary Supplement: Standard oral nutritional supplement

Immunonutrition

EXPERIMENTAL

Oral nutritional supplements with immunonutrition

Dietary Supplement: Oral nutritional supplement with inmmunonutrition

Interventions

Oral nutritional supplement with inmmunonutrition DIETARY_SUPPLEMENT

Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid)

Immunonutrition

Standard oral nutritional supplement DIETARY_SUPPLEMENT

Oral nutritional supplement with high protein content but not enriched with arginine or any other component of immunonutrition

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for colorectal cancer surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Sarcopenia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 17, 2026
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)