Nutritional Supplementation to Improve Colorectal Cancer Surgery

NCT07599501 | Not Yet Recruiting

• 1 other identifier: CHR1-11-2025
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Colorectal Surgery

Keywords

Colorectal cancer; Colorectal surgery; Oral Nutritional Supplementation

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  The rate of postoperative complications occurring within 30 days from surgery

  30 days from surgery

Secondary Outcomes (9)

• Postoperative septic complications

  30 days from surgery

• Comprehensive Complication Index (CCI)

  30 days from surgery

• Length of hospital stay

  30 days from surgery

• Hospital readmission

  30 days from surgery

• Sarcopenia

  Six months after surgery

Study Arms (2)

Diet optimization (DO)

ACTIVE COMPARATOR

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)

Diet Optimization and Oral Nutritional Supplementation (DO+ONS)

EXPERIMENTAL

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 Supplement: Oral Nutritional Supplement (ONS)

Interventions

Diet Optimization (DO) OTHER

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.

Diet Optimization and Oral Nutritional Supplementation (DO+ONS); Diet optimization (DO)

Oral Nutritional Supplement (ONS) DIETARY_SUPPLEMENT

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).

Diet Optimization and Oral Nutritional Supplementation (DO+ONS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged more than 18 years old.
• Histological diagnosis of colorectal adenocarcinoma.
• Participants scheduled for elective minimally invasive colorectal resection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Antonino Spinell, MD, PhD

  Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Maroli, PhD

CONTACT

00390282247776; annalisa.maroli@humanitas.it

Stefano De Zanet, MS

CONTACT

00390282244623; stefano.dezanet@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)