Perioperative Immunonutrition Under Enhanced Recovery After Surgery

NCT06039306 | Recruiting

• 1 other identifier: RSCH ID-22-04215-WHE
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecological Cancer; Elective Surgery

Keywords

gynecological cancer, elective surgery

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Functional status

  1 month

• stress level

  1 month

Study Arms (2)

intervention

EXPERIMENTAL

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

conventional

NO INTERVENTION

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.

Interventions

Immunonutrition oral nutrition supplementation DIETARY_SUPPLEMENT

Participant will prescribed with 2 servings of immunonutrition supplement 5 days before surgery and 7 days after surgery

intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who diagnosed with GC
• Candidates for elective operation treatments

You may not qualify if:

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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Institut Kanser Negara

Putrajaya, Putrajaya, 62250, Malaysia

RECRUITING

Related Publications (8)

• 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.

  PMID: 29623417 BACKGROUND

• 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.

  PMID: 28289508 BACKGROUND

• 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.

  PMID: 27637832 BACKGROUND

• 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.

  PMID: 35011097 BACKGROUND

• 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.

  PMID: 31968595 BACKGROUND

• 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.

  PMID: 29999517 BACKGROUND

• 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.

  PMID: 35353297 BACKGROUND

• Ho C, Daud ZAM, Mohd Yusof BN, Abdul Majid H. Perioperative immunonutrition intervention on postoperative outcomes among gynecological cancer patients under enhanced recovery after surgery setting: A study protocol of explanatory mixed method study. PLoS One. 2024 Dec 31;19(12):e0315568. doi: 10.1371/journal.pone.0315568. eCollection 2024.

  PMID: 39739975 DERIVED

Study Officials

• ChiouYi Ho

  National Cancer Institute, Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ChiouYi Ho

CONTACT

0388925555; agneshcy0326@gmail.com

Zulfitri 'Azuan Mat Daud

CONTACT

zulfitri@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 15, 2023
• Study Start: September 1, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 19, 2025

Record last verified: 2024-08

Locations

MY (1)