Immunonutrition in ERAS Protocols in Gynecologic Oncology

Not Applicable

Recruiting

• Conditions: ERAS; Gynecologic Cancer; Nutritional Deficiency
• Interventions: Dietary Supplement: Immunonutrition

• Registration Number: NCT06103526
• Lead Sponsor: National and Kapodistrian University of Athens

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.

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 Timeline

• Study First Submitted: 2023-10-16
• Study Start: 2023-10-18
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-05-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunonutrition and ERAS	Immunonutrition	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

First department of Obstetrics and Gynecology; 🇬🇷 Athens, Greece