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Nutritional Supplementation to Improve Colorectal Cancer Surgery (NUTRICOLOR)

13. maj 2026 opdateret af: Istituto Clinico Humanitas

Perioperative Nutritional Supplementation to Prevent Postoperative Complications and Improve Postoperative Outcomes After Colorectal Cancer Surgery: a Single-center Unblinded Randomized Controlled Trial

This study aims to explore the effectiveness of perioperative Oral Nutritional Supplementation (ONS) combined with an optimized, tailored diet in reducing the risk of postoperative complications and improving the nutritional status of colorectal cancer patients scheduled for curative colorectal resection.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The rate of postoperative complications after colorectal cancer surgery is around 35%. The preoperative nutritional status significantly influences the postoperative outcomes, and several studies have investigated the effect of perioperative nutritional interventions with mixed results. This study aims to explore the effect of perioperative Oral Nutritional Supplementation (ONS) on the postoperative outcomes of colorectal cancer patients receiving preoperative dietary optimization. Participants scheduled for elective curative colorectal cancer surgery will undergo a detailed preoperative nutritional screening and will be randomized to receive either an optimized diet alone or an optimized diet and perioperative ONS. Postoperative complications will be collected and registered until 60 days after surgery. The participants' nutritional status will be evaluated 60 days and 180 days after surgery.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

190

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Italien
    • Milano
      • Rozzano, Milano, Italien, 20089

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

  • Participants aged more than 18 years old.
  • Histological diagnosis of colorectal adenocarcinoma.
  • Participants scheduled for elective minimally invasive colorectal resection.
  • Participants with a preoperative MUST score equal to or below 2. Exclusion criteria
  • Any condition that, in the opinion of the investigator, may interfere with the study procedures.
  • Emergent surgery.
  • Planned open surgery. Participants undergoing unplanned surgical conversion (from minimally invasive to open) will be withdrawn from the study.
  • Any concomitant surgery unrelated to the primitive colorectal cancer (for example, concomitant liver metastasis resection).
  • Participants with preoperative MUST score > 2.
  • Pregnant or breastfeeding participants. Women of childbearing potential must agree to use a reliable contraceptive method. Otherwise, a pregnancy urine test must be performed at each study visit to exclude a potential pregnancy.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Diet optimization (DO)
Dietary optimization will include a tailored diet to maintain or restore a good nutritional status, body composition (e.g. weight or lean mass gain if necessary), and macro/micronutrient intake in case of deficiencies detected during the nutritional screening. Participants will be instructed to follow the dietary indications throughout the study, with appropriate adjustments according to following nutritional assessments.
Andet: Diet Optimization (DO)
Dietary optimization will include a tailored diet to maintain or restore a good nutritional status, body composition (e.g. weight or lean mass gain if necessary), and macro/micronutrient intake in case of deficiencies detected during the nutritional screening. Participants will be instructed to follow the dietary indications throughout the study, with appropriate adjustments according to following nutritional assessments.
Eksperimentel: Diet Optimization and Oral Nutritional Supplementation (DO+ONS)
Participants in the DO+ONS arm will receive dietary optimization and standardized oral nutritional supplementation designed according to the ESPEN guidelines. The treatment will start 14 days before surgery and will be restored the day after surgery for the following 60 days.
Andet: Diet Optimization (DO)
Dietary optimization will include a tailored diet to maintain or restore a good nutritional status, body composition (e.g. weight or lean mass gain if necessary), and macro/micronutrient intake in case of deficiencies detected during the nutritional screening. Participants will be instructed to follow the dietary indications throughout the study, with appropriate adjustments according to following nutritional assessments.
Kosttilskud: Oral Nutritional Supplement (ONS)
ONS will consist of LH Blu® (Lionhealth Italia Srl). LH Blu® is categorized as a food for special medical purposes and is indicated for the treatment of malnourished patients. ONS will start 14 days before the planned intervention with a tailored dosage decided according to the malnutrition risk (low vs medium).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative complications
Tidsramme: 30 days from surgery
The rate of postoperative complications occurring within 30 days from surgery
30 days from surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative septic complications
Tidsramme: 30 days from surgery
The rate of postoperative septic complications occurring within 30 days from surgery. Septic complications are defined according to the criteria proposed by the International Sepsis Definitions Conference and include documented postoperative extra-intestinal infections- such as urinary tract infections and pneumonia-, intra-abdominal septic complications- such as anastomotic leaks, pelvic abscesses, and peritonitis-, surgical site infections, and systemic symptoms of abnormal inflammatory response- such as fever higher than 38°C or C-Reactive Protein (CRP) increase higher than 200 mg/dL for more than two consecutive days
30 days from surgery
Comprehensive Complication Index (CCI)
Tidsramme: 30 days from surgery
The median Comprehensive Complication Index (CCI) computed from all postoperative complications that occurred within 30 days from surgery. The CCI ranges from 0 to 100, where 0 indicates the best outcome (no postoperative complications), and 100 indicates the worst outcome (postoperative complications leading to death).
30 days from surgery
Length of hospital stay
Tidsramme: 30 days from surgery
The median length of hospital stay calculated in days from the day after surgery until the day of discharge
30 days from surgery
Hospital readmission
Tidsramme: 30 days from surgery
The rate of hospital readmissions- including ward readmission and emergency room accesses- within 30 days from surgery
30 days from surgery
Sarcopenia
Tidsramme: Six months after surgery
The proportion of participants with sarcopenia six months after surgery. Sarcopenia will be assessed from the Skeletal Muscle Index (SMI) computed from the abdominal Computed Tomography (CT) scans collected at screening and 6 months after surgery. SMI less than 7.0 kg/m2 for men and less than 5.5 kg/m2 for women will be considered indicative of sarcopenia.
Six months after surgery
Normal weight
Tidsramme: 60 days after surgery
The proportion of participants with normo-weight Body Mass Index (BMI) measures at 60 days after surgery. Normal BMI values ranges from 18.5 Kg/m2 and 24.9 Kg/m2.
60 days after surgery
Mini Nutritional Assessment (MNA) score
Tidsramme: 60 days after surgery
The median Mini Nutritional Assessment (MNA) score collected 60 days after surgery. The MNA score ranges from 0 (worst possibile nutritional status) to 30 (best possible nutritional status).
60 days after surgery
EuroQoL-5 Dimension- 5 Levels (EQ5D5L) score
Tidsramme: 60 days after surgery
The median EuroQoL-5 Dimension- 5 Levels (EQ5D5L) score collected 60 days after surgery. The EQ5D5L score ranges from 0 (worst possible perceived health) to 25 (best possible perceived health).
60 days after surgery
Proctitis
Tidsramme: Six months after surgery
The proportion of participants with clinical signs of active proctitis six months after surgery. Active proctitis will be assessed through rigid or flexible sigmoidoscopy and will be defined by the presence of any of the following findings: friable mucosa with edema, oozing, or ulcerations; bleeding; wall thickening; pseudopolyps; strictures; stenosis; loss of normal curvature; necrosis; perforations; fistula. The severity of proctitis will be classified using the RTOG/EORTC grading system
Six months after surgery

Samarbejdspartnere og efterforskere

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

Sponsor

Istituto Clinico Humanitas

Efterforskere

  • Ledende efterforsker: Antonino Spinell, MD, PhD, Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy

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 (Anslået)

30. september 2026

Primær færdiggørelse (Anslået)

28. februar 2028

Studieafslutning (Anslået)

28. februar 2028

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHR1-11-2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

According to the Promoter Standard Operative Procedures, IPD will be uploaded in a public open-access repository (Zenodo). IPD will be made available upon request by sendind an email to biblioteca@humanitas.it

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Kliniske forsøg med Kolorektal cancer

Kliniske forsøg med Diet Optimization (DO)

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