PING-ERAS: Perioperative Immunonutrition Under Enhanced Recovery After Surgery

Sponsor

Universiti Putra Malaysia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06039306

Collaborator

(none)

106

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecological Cancer Elective Surgery	Dietary Supplement: Immunonutrition oral nutrition supplementation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

After consented, participants will be randomized into two groups: the intervention group and conventional group during consultation in multidisciplinary clinic.After consented, participants will be randomized into two groups: the intervention group and conventional group during consultation in multidisciplinary clinic.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

daily energy and protein intake [1 month]
24-hours diet recall
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
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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Kanser Negara (National Cancer Institute)	Putrajaya		Malaysia	62250

Sponsors and Collaborators

Universiti Putra Malaysia

Investigators

Principal Investigator: ChiouYi Ho, National Cancer Institute, Malaysia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ChiouYi Ho, Principal Investigator, Universiti Putra Malaysia

ClinicalTrials.gov Identifier:

NCT06039306

Other Study ID Numbers:

RSCH ID-22-04215-WHE

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ChiouYi Ho, Principal Investigator, Universiti Putra Malaysia

gynecological cancer, elective surgery

Study Results

No Results Posted as of Sep 15, 2023