Nutritional Supplementation to Improve Colorectal Cancer Surgery (NUTRICOLOR)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Colorectal Surgery
• Intervention / Treatment: Other: Diet Optimization (DO); Dietary supplement: Oral Nutritional Supplement (ONS)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annalisa Maroli, PhD; Phone Number: 00390282247776; Email: annalisa.maroli@humanitas.it
• Study Contact Backup: Name: Stefano De Zanet, MS; Phone Number: 00390282244623; Email: stefano.dezanet@humanitas.it

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • IRCCS Humanitas Research Hospital
      • Principal Investigator: Antonino Spinelli, MD, PhD
      • Contact: Annalisa Maroli, PhD; Phone Number: 00390282247776; Email: annalisa.maroli@humanitas.it
      • Contact: Stefano De Zanet, MS; Phone Number: 00390282244623; Email: stefano.dezanet@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Experimental: 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.	Other: 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.; Dietary supplement: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	The rate of postoperative complications occurring within 30 days from surgery	30 days from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative septic complications	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)	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	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	The rate of hospital readmissions- including ward readmission and emergency room accesses- within 30 days from surgery	30 days from surgery
Sarcopenia	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Antonino Spinell, MD, PhD, Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal cancer; Colorectal surgery; Oral Nutritional Supplementation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: CHR1-11-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No