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NCT Number: NCT07653737

Immunonutrition for Prehabilitation of Patients With Colorectal Cancer Before Surgery

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.

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Key information

Conditions

Colorectal Cancer Atrophy Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Aspect of Cancer Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral nutritional supplement with inmmunonutrition

Dietary Supplement

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

Standard Oral Nutritional Supplement

Dietary Supplement

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

Primary outcomes

  1. Post-surgical complications

    Time frame: From surgery until 90 days post-hospital discharge

    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

  1. Weight (Kg)

    Time frame: From preoperative evaluation until 90 days after hospital discharge

    Weight of the patient at each visit

  2. Height (cm)

    Time frame: From preoperative evaluation until 90 days after hospital discharge

    Height of the patient at each visit

  3. BMI (Kg/m2)

    Time frame: From preoperative evaluation until 90 days after hospital discharge

    Body mass index of the patients calculated using weight and height

  4. Weight loss (%)

    Time frame: From preoperative evaluation until 90 days after hospital discharge

    Percentage of weight loss from the preoperative baseline weight of the patient

  5. MUST (malnutrition universal screening tool) score.

    Time frame: 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 universal screening tool) score.

  6. Muscle mass - SMMI (cm2/m2)

    Time frame: From preoperative evaluation until 90 days adter surgery

    Body composition was quantified using preoperative and first postoperative CT scans, analyzing skeletal muscle mass index (SMMI), psoas area, periabdominal musculature, and fat compartments.

  7. Psoas muscle index (cm2/m2)

    Time frame: 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.

  8. Subcutaneous fat tissue (cm2)

    Time frame: 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, periabdominal musculature, and fat compartments.

  9. Visceral fat tissue (cm2)

    Time frame: 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, periabdominal musculature, and fat compartments.

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

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

Acronym: IMNUTPREH-CRC

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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