NCT07653737Completed
Immunonutrition for Prehabilitation of Patients With Colorectal Cancer Before Surgery
Study of Nutritional Management for Prehabilitation: Surgical and Nutritional Outcomes in Patients With Colorectal Cancer Treated With Oral Nutritional Supplements With and Without Immunonutrition.
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 10 Jun 2026
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Diseases
- Colorectal cancer
- NCT number
- NCT07653737
What you commit to
- Study type: Interventional
- Participants enrolled: 56
- From 1 Jan 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery
- Previous nutritional supplements
Other illness
- Non-surgical colorectal cancer
- End-stage liver o kidney disease
- Hypersensitivity to arginine, omega-3, or nucleotides
- HIV infection
- Active uncontrolled infection
- Dementia, advanced degenerative neurological disease.
Other
- Inability for oral nutrition (dysphagia, esophageal/pyloric stenosis)
- Pregnancy
- Intestinal obstruction
Who the study is looking for
- Patients eligible for colorectal cancer surgery
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.