Perioperative Immunonutrition Under Enhanced Recovery After Surgery (PING-ERAS)

September 8, 2023 updated by: ChiouYi Ho, Universiti Putra Malaysia

Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
      • Putrajaya, Malaysia, 62250
        • Institut Kanser Negara (National Cancer Institute)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
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
Participant will prescribed with 2 servings of immunonutrition supplement 5 days before surgery and 7 days after surgery
No Intervention: conventional
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
daily energy and protein intake
Time Frame: 1 month
24-hours diet recall
1 month
body composition
Time Frame: 1 month
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
Time Frame: 1 month
Concentration of immunoglobulin G; Concentration of immunoglobulin A; Concentration of immunoglobulin M
1 month
C-reactive protein
Time Frame: 1 month
Concentration of C-reactive protein
1 month
postoperative outcomes
Time Frame: 1 months
length of hospitalization
1 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Investigators

  • Principal Investigator: ChiouYi Ho, National Cancer Institute, Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSCH ID-22-04215-WHE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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