Perioperative Immunonutrition Under Enhanced Recovery After Surgery

Not Applicable

Not yet recruiting

• Conditions: Gynecological Cancer; Elective Surgery
• Interventions: Dietary Supplement: Immunonutrition oral nutrition supplementation

• Registration Number: NCT06039306
• Lead Sponsor: Universiti Putra Malaysia

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Study Start: 2024-09-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 106

Inclusion Criteria

1. Those who diagnosed with GC
2. Candidates for elective operation treatments

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Exclusion Criteria

1. Those are involved gastrointestinal tract (complication)
2. Those are diagnosed with GC (metastasis)
3. Allergy to milk/soy/whey protein
4. Participate in other intervention study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Immunonutrition oral nutrition supplementation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
stress level	1 month	questionnaire 10-item perceived stress scale (PSS-10) form
Functional status	1 month	handgrip strength in kg via Jammar dynamometer

Trial Locations

Locations (1)

Institut Kanser Negara (National Cancer Institute); 🇲🇾 Putrajaya, Malaysia