NUTRIGO: Immunonutrition in ERAS Protocols in Gynecologic Oncology

Sponsor

National and Kapodistrian University of Athens (Other)

Overall Status

Recruiting

CT.gov ID

NCT06103526

Collaborator

(none)

200

Enrollment

Location

Arms

22.4

Anticipated Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional Deficiency Gynecologic Cancer ERAS	Dietary Supplement: Immunonutrition	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Immunonutrition and Enhanced Recovery After Surgery Protocols in Gynecologic Oncology

Actual Study Start Date :

Oct 18, 2023

Anticipated Primary Completion Date :

May 30, 2025

Anticipated Study Completion Date :

Aug 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Perioperative infections [Postoperatively (30 days)]
We will notice possible surgical site infections,respiratory inflammations etc and calculate inflammatory markers and the concentration of white blood cells
Duration of hospitalization [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.

Secondary Outcome Measures

Postoperative mobilization [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.
Postoperative morbidity (other than infectious) [30 days]
Major events such as pulmonary embolism,accuse myocardial infarction,etc
Recurrence rates [3 years follow-up]
Recurrent disease will be monitored through 3 year of follow up
Overall survival [3 years follow-up]
Overall survival of the patients will be measured through 3 year of follow up

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First department of Obstetrics and Gynecology	Athens		Greece	11523

Sponsors and Collaborators

National and Kapodistrian University of Athens

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Nikolaos Thomakos, Associate Professor of Obstetrics and Gynecology, National and Kapodistrian University of Athens

ClinicalTrials.gov Identifier:

NCT06103526

Other Study ID Numbers:

1233456

First Posted:

Oct 26, 2023

Last Update Posted:

Oct 26, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of Oct 26, 2023