Immunonutrition in ERAS Protocols in Gynecologic Oncology (NUTRIGO)

March 27, 2024 updated by: Nikolaos Thomakos, National and Kapodistrian University of Athens

Immunonutrition and Enhanced Recovery After Surgery Protocols in Gynecologic Oncology

A patient with oncological pathology of any type because of impaired digestion and nutrient absorption, decreased intake, and increased nutrition requirements has an increased risk of malnutrition and moderate to severe weight loss.In the present study the investigators will evaluate the impact of perioperative immunonutrition supplementation on the postoperative outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Malnutrition has a major effect not only on the postoperative course of cancer surgery but can also complicate or even limit administration or compromise the effectiveness of other treatments such as chemotherapy or radiotherapy in the perioperative period. Immunonutrition is a type of artificial nutrition based on the use of some types of macro- or micronutrients.The purpose of this review was to evaluate the use, indications, and effects of these formulas in oncologic surgical patients in real time and to identify the types of patients who can benefit from enteral immunonutrition.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Greece
      • Athens, Greece, 11523
        • Recruiting
        • First department of Obstetrics and Gynecology
        • Contact:

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

Description

Inclusion Criteria:

  • women with any gynaecologic malignancy enrolled in surgical list of our institute
  • must be able to consume oral supplements.

Exclusion Criteria:

  • women that are not able to follow ERAS protocol due to medical reasons
  • patients with severe disease that cannot compromise with protocol

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immunonutrition and ERAS
Immunonutrition supplements will be provided to patients in the form of oral supplements given twice daily for 3 days pre-surgery and 3 days post-surgery.
Dietary supplement: Immunonutrition
enteral supplementation with high amount of proteins, arginine, glutamine, nonessential fatty acids, branched chain fatty acids, nucleotides, or RNA
No Intervention: ERAS without immunonutrition
Typical ERAS protocol will be followed for patients in that group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative infections
Time Frame: Postoperatively (30 days)
We will notice possible surgical site infections,respiratory inflammations etc and calculate inflammatory markers and the concentration of white blood cells
Postoperatively (30 days)
Duration of hospitalization
Time Frame: Until discharge from hospital
From date of hospitalization until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.
Until discharge from hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative mobilization
Time Frame: Until first day of mobilization
From date of surgery until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.
Until first day of mobilization
Postoperative morbidity (other than infectious)
Time Frame: 30 days
Major events such as pulmonary embolism,accuse myocardial infarction,etc
30 days
Recurrence rates
Time Frame: 3 years follow-up
Recurrent disease will be monitored through 3 year of follow up
3 years follow-up
Overall survival
Time Frame: 3 years follow-up
Overall survival of the patients will be measured through 3 year of follow up
3 years follow-up

Collaborators and Investigators

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

Sponsor

National and Kapodistrian University of Athens

Investigators

  • Study Director: Nikolaos Thomakos, Pf, National Kapodistrian University of Athens,1st obs and gyn department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 18, 2023

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1233456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual patient data will become available upon reasonable request

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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