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Nutritional Supplementation to Improve Colorectal Cancer Surgery

NCT07599501 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2026-05-20

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-02-28
Completion
2028-02-28

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07599501 on ClinicalTrials.gov