Multidisciplinary Approach to Nutritional Support for Oncological Patients - NUTRACARE PROJECT (NUTRACARE)

March 6, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Malnutrition correlated to increased perioperative morbidity occurs in patients with gastrointestinal malignancies.

Adherence guidelines for nutritional assessment and support in oncological patients is unfortunately very low.

The aim of the study is to improve clinical practice by using and testing the digital platform NUTRACARE in 5 different Centers.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

After being informed about the study, all the patients undergoing elective surgery or first cycle of neoadjuvant or adjuvant therapy giving written informed consent will be screened by the surgeon or the oncologist and the NRS-2002 (Nutrition Risk Screening) will be administered.

Patients who will be assessed at risk will be notified to the center nutritionist.

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy
        • Fondazione Policlinico Universitario A. Gemelli, IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with gastrointestinal neoplasms

Description

Inclusion Criteria:

  • <18 years
  • ECOG grade 0-2
  • Patients undergoing elective surgery or first cycle of chemotherapy (neoadjuvant or adjuvant) for staged I-III colorectal, hepatobiliary-pancreatic and oesophago-gastric cancers

Exclusion Criteria:

  • >18 years
  • Pregnancy
  • Emergency
  • ECOG ≥ 3
  • M+
  • Peritoneal involvement
  • Inability to provide informed consent
  • Informed consent refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional intervention
Time Frame: 15 days
Number and type of nutritional interventions required
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: up tp 30 days
Number and severity of surgical and oncological complications
up tp 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Domenico D'Ugo, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Actual)

July 17, 2023

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4982

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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