Immunonutrition in ERAS Protocols in Gynecologic Oncology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immunonutrition and Enhanced Recovery After Surgery Protocols in Gynecologic Oncology

Conditions
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Nutritional Deficiency, Gynecologic Cancer, ERAS

Intervention / Treatment
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* Dietary Supplement: Immunonutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immunonutrition and ERAS<br>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<br>* enteral supplementation with high amount of proteins, arginine, glutamine, nonessential fatty acids, branched chain fatty acids, nucleotides, or RNA<br>|
| No Intervention: ERAS without immunonutrition<br>Typical ERAS protocol will be followed for patients in that group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative infections | 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 | 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 | 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) | Major events such as pulmonary embolism,accuse myocardial infarction,etc | 30 days | 
| Recurrence rates | Recurrent disease will be monitored through 3 year of follow up | 3 years follow-up | 
| Overall survival | Overall survival of the patients will be measured through 3 year of follow up | 3 years follow-up |