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Trial Title:
Immunonutrition in ERAS Protocols in Gynecologic Oncology
NCT ID:
NCT06103526
Condition:
Nutritional Deficiency
Gynecologic Cancer
ERAS
Conditions: Official terms:
Malnutrition
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Immunonutrition
Description:
enteral supplementation with high amount of proteins, arginine, glutamine, nonessential
fatty acids, branched chain fatty acids, nucleotides, or RNA
Arm group label:
Immunonutrition and ERAS
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First department of Obstetrics and Gynecology
Address:
City:
Athens
Zip:
11523
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Vasilios Pergialiotis, MD
Phone:
+306947326459
Email:
pergialiotis@yahoo.com
Start date:
October 18, 2023
Completion date:
August 30, 2025
Lead sponsor:
Agency:
National and Kapodistrian University of Athens
Agency class:
Other
Source:
National and Kapodistrian University of Athens
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06103526
