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

16. juni 2026 opdateret af: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

56

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control
Standard oral nutritional supplements
Kosttilskud: Standard oral nutritional supplement
Oral nutritional supplement with high protein content but not enriched with arginine or any other component of immunonutrition
Eksperimentel: Immunonutrition
Oral nutritional supplements with immunonutrition
Kosttilskud: Oral nutritional supplement with inmmunonutrition
Oral nutritional supplements with immunonutrition (enriched with arginine, nucleotides, vitamin D and omega-3-fatty acid)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-surgical complications
Tidsramme: 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).
From surgery until 90 days post-hospital discharge

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight (Kg)
Tidsramme: From preoperative evaluation until 90 days after hospital discharge
Weight of the patient at each visit
From preoperative evaluation until 90 days after hospital discharge
Height (cm)
Tidsramme: From preoperative evaluation until 90 days after hospital discharge
Height of the patient at each visit
From preoperative evaluation until 90 days after hospital discharge
BMI (Kg/m2)
Tidsramme: From preoperative evaluation until 90 days after hospital discharge
Body mass index of the patients calculated using weight and height
From preoperative evaluation until 90 days after hospital discharge
Weight loss (%)
Tidsramme: From preoperative evaluation until 90 days after hospital discharge
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.
Tidsramme: 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.
From preoperative evaluation until 90 days after hospital discharge
Muscle mass - SMMI (cm2/m2)
Tidsramme: 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.
From preoperative evaluation until 90 days adter surgery
Psoas muscle index (cm2/m2)
Tidsramme: 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.
From preoperative evaluation until 90 days after hospital discharge
Subcutaneous fat tissue (cm2)
Tidsramme: 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.
From preoperative evaluation until 90 days after hospital discharge
Visceral fat tissue (cm2)
Tidsramme: 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.
From preoperative evaluation until 90 days after hospital discharge

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2024

Primær færdiggørelse (Faktiske)

31. december 2025

Studieafslutning (Faktiske)

31. marts 2026

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PI118/22

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Kolorektal cancer

Kliniske forsøg med Standard oral nutritional supplement

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