Multidisciplinary Approach to Nutritional Support for Onc... | NCT06869707

Studies
Multidisciplinary Approach to Nutritional Support for Oncological Patients - NUTRACARE PROJECT

NCT06869707

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Active, not recruiting

Last Update Posted

Mar 11, 2025Actual

Enrollment

85Actual

Phase

Not provided

Conditions

Gastrointestinal Neoplasms

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2023Actual

Primary Completion Date

Jul 17, 2023Actual

Completion Date

Jul 1, 2025Estimated

First Submitted Date

Mar 6, 2025

First Submission Date that Met QC Criteria

Mar 6, 2025

First Posted Date

Mar 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2025

Last Update Posted Date

Mar 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with gastrointestinal neoplasms

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Domenico D'Ugo	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario A. Gemelli, IRCCS		Roma			Italy

Condition Browse Module

MeSH Terms

ID	Term
D005770	Gastrointestinal Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided