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History of Changes for Study: NCT06039306
Perioperative Immunonutrition Under Enhanced Recovery After Surgery (PING-ERAS)
Latest version (submitted September 8, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 8, 2023 None (earliest Version on record)
Comparison Format:
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Study NCT06039306
Submitted Date:  September 8, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: RSCH ID-22-04215-WHE
Brief Title: Perioperative Immunonutrition Under Enhanced Recovery After Surgery (PING-ERAS)
Official Title: Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2023
Overall Status: Not yet recruiting
Study Start: December 1, 2023
Primary Completion: December 31, 2024 [Anticipated]
Study Completion: June 30, 2025 [Anticipated]
First Submitted: August 24, 2023
First Submitted that
Met QC Criteria:		 September 8, 2023
First Posted: September 15, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 September 8, 2023
Last Update Posted: September 15, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Universiti Putra Malaysia
Responsible Party: Principal Investigator
Investigator: ChiouYi Ho
Official Title: Principal Investigator
Affiliation: Universiti Putra Malaysia
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.
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.
Open or close this module Conditions
Conditions: Gynecological Cancer
Elective Surgery
Keywords: gynecological cancer, elective surgery
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
After consented, participants will be randomized into two groups: the intervention group and conventional group during consultation in multidisciplinary clinic.
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 106 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. daily energy and protein intake
[ Time Frame: 1 month ]

24-hours diet recall
2. 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
3. immunoglobulin level
[ Time Frame: 1 month ]

Concentration of immunoglobulin G; Concentration of immunoglobulin A; Concentration of immunoglobulin M
4. C-reactive protein
[ Time Frame: 1 month ]

Concentration of C-reactive protein
5. postoperative outcomes
[ Time Frame: 1 months ]

length of hospitalization
Secondary Outcome Measures:
1. Functional status
[ Time Frame: 1 month ]

handgrip strength in kg via Jammar dynamometer
2. stress level
[ Time Frame: 1 month ]

questionnaire 10-item perceived stress scale (PSS-10) form
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: ChiouYi Ho
Telephone: 0388925555 Ext. 3404
Email: agneshcy0326@gmail.com
Central Contact Backup: Zulfitri 'Azuan Mat Daud
Email: zulfitri@upm.edu.my
Study Officials: ChiouYi Ho
Principal Investigator
National Cancer Institute, Malaysia
Locations: Malaysia
Institut Kanser Negara (National Cancer Institute)
Putrajaya, Malaysia, 62250
Contact:Contact: ChiouYi Ho 0127603622 Ext. 3404 agneshcy0326@gmail.com
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations: [Study Results] Hertlein L, Zeder-Goss C, Furst S, Bayer D, Trillsch F, Czogalla B, Mahner S, Burges A, Rittler P. Peri-operative oral immunonutrition in malnourished ovarian cancer patients assessed by the nutritional risk screening. Arch Gynecol Obstet. 2018 Jun;297(6):1533-1538. doi: 10.1007/s00404-018-4759-8. Epub 2018 Apr 5. PubMed 29623417
[Study Results] Abeles A, Kwasnicki RM, Darzi A. Enhanced recovery after surgery: Current research insights and future direction. World J Gastrointest Surg. 2017 Feb 27;9(2):37-45. doi: 10.4240/wjgs.v9.i2.37. PubMed 28289508
[Study Results] Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6. PubMed 27637832
[Study Results] Ho CY, Ibrahim Z, Abu Zaid Z, Mat Daud ZA, Mohd Yusop NB, Mohd Abas MN, Omar J. Postoperative Dietary Intake Achievement: A Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2022 Jan 5;14(1):222. doi: 10.3390/nu14010222. PubMed 35011097
[Study Results] Yi HC, Ibrahim Z, Abu Zaid Z, Mat Daud Z', Md Yusop NB, Omar J, Mohd Abas MN, Abdul Rahman Z, Jamhuri N. Impact of Enhanced Recovery after Surgery with Preoperative Whey Protein-Infused Carbohydrate Loading and Postoperative Early Oral Feeding among Surgical Gynecologic Cancer Patients: An Open-Labelled Randomized Controlled Trial. Nutrients. 2020 Jan 20;12(1):264. doi: 10.3390/nu12010264. PubMed 31968595
[Study Results] Mudge LA, Watson DI, Smithers BM, Isenring EA, Smith L, Jamieson GG; Australian Immunonutrition Study Group. Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer. Br J Surg. 2018 Sep;105(10):1262-1272. doi: 10.1002/bjs.10923. Epub 2018 Jul 12. PubMed 29999517
[Study Results] Di Renzo L, De Lorenzo A, Fontanari M, Gualtieri P, Monsignore D, Schifano G, Alfano V, Marchetti M; SIERR. Immunonutrients involved in the regulation of the inflammatory and oxidative processes: implication for gamete competence. J Assist Reprod Genet. 2022 Apr;39(4):817-846. doi: 10.1007/s10815-022-02472-6. Epub 2022 Mar 30. PubMed 35353297
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