Perioperative Immunonutrition Under Enhanced Recovery After Surgery

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the effect of perioperative immunonutrition supplement in gynecologic cancer patients. The main questions it aims to answer are: is there any difference in the nutritional outcomes and functional outcomes between intervention and conventional groups? is there any difference in the post-surgical outcomes between intervention and conventional groups? Participants (intervention) will be provided the immunonutrition supplement before and after operation. Researchers will compare intervention group with conventional group to see if there is any difference in postoperative outcomes.

Detailed Description
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The clinical trial aims to determine the effectiveness of perioperative IMN intervention on postoperative outcomes among GC patients under Enhanced Recovery after Surgery (ERAS) setting. Patients will prescribed with immunonutrition supplement before and after surgery.

Official Title
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Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery

Conditions
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Gynecological Cancer, Elective Surgery

Intervention / Treatment
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* Dietary Supplement: Immunonutrition oral nutrition supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who diagnosed with GC Candidates for elective operation treatments Exclusion Criteria: Those are involved gastrointestinal tract (complication) Those are diagnosed with GC (metastasis) Allergy to milk/soy/whey protein Participate in other intervention study

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: After consented, participants will be randomized into two groups: the intervention group and conventional group during consultation in multidisciplinary clinic.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>Participants will be given 2 servings immunonutrition daily for five (5) days before tentative elective surgery. ERAS protocol will implement and continued 2 servings of immunonutrition for post-operative seven (7) days. | Dietary Supplement: Immunonutrition oral nutrition supplementation<br>* Participant will prescribed with 2 servings of immunonutrition supplement 5 days before surgery and 7 days after surgery<br>|
| No Intervention: conventional<br>Participants will be on usual diet intake before tentative elective surgery. ERAS protocol will implement and will be prescribed 2 servings of polymeric formula daily only if unable to finish 75% of the diet served in ward. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily energy and protein intake | 24-hours diet recall | 1 month | 
| body composition | body composition analyzer; weight in kg; fat free mass in kg; fat mass in kg; muscle mass in kg; height in meter | 1 month | 
| immunoglobulin level | Concentration of immunoglobulin G; Concentration of immunoglobulin A; Concentration of immunoglobulin M | 1 month | 
| C-reactive protein | Concentration of C-reactive protein | 1 month | 
| postoperative outcomes | length of hospitalization | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status | handgrip strength in kg via Jammar dynamometer | 1 month | 
| stress level | questionnaire 10-item perceived stress scale (PSS-10) form | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gynecological cancer, elective surgery