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Active, Not Recruiting

NCT Number: NCT06869707

Multidisciplinary Approach to Nutritional Support for Oncological Patients - NUTRACARE PROJECT

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gastrointestinal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Roma, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Nutritional intervention

    Time frame: 15 days

    Number and type of nutritional interventions required

Secondary outcomes

  1. Complications

    Time frame: up tp 30 days

    Number and severity of surgical and oncological complications

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: NUTRACARE

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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