Multidisciplinary Approach to Nutritional Support for Oncological Patients - NUTRACARE PROJECT

Active, not recruiting

• Conditions: Gastrointestinal Neoplasms

• Registration Number: NCT06869707
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

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 Timeline

• Study Start: 2023-07-03
• Primary Completion: 2023-07-17
• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nutritional intervention	15 days	Number and type of nutritional interventions required

Secondary Outcome Measures

Name	Time	Method
Complications	up tp 30 days	Number and severity of surgical and oncological complications

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli, IRCCS; 🇮🇹 Roma, Italy