Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Nutritional Supplementation to Improve Colorectal Cancer Surgery (NUTRICOLOR)

13 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

190

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Italia
    • Milano
      • Rozzano, Milano, Italia, 20089
        • IRCCS Humanitas Research Hospital
        • Investigatore principale:
          • Antonino Spinelli, MD, PhD
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: 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.
Sperimentale: 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.
Altro: 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.
Integratore alimentare: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative complications
Lasso di tempo: 30 days from surgery
The rate of postoperative complications occurring within 30 days from surgery
30 days from surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative septic complications
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Istituto Clinico Humanitas

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 settembre 2026

Completamento primario (Stimato)

28 febbraio 2028

Completamento dello studio (Stimato)

28 febbraio 2028

Date di iscrizione allo studio

Primo inviato

4 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 maggio 2026

Primo Inserito (Effettivo)

20 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CHR1-11-2025

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cancro colorettale

Prove cliniche su Diet Optimization (DO)

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Kenya

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi