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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunonutrition oral nutrition supplementation | Dietary Supplement | Participant will prescribed with 2 servings of immunonutrition supplement 5 days before surgery and 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status | handgrip strength in kg via Jammar dynamometer | 1 month |
| stress level | questionnaire 10-item perceived stress scale (PSS-10) form |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ChiouYi Ho | Contact | 0388925555 | 3404 | agneshcy0326@gmail.com |
| Zulfitri 'Azuan Mat Daud | Contact | zulfitri@upm.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| ChiouYi Ho | National Cancer Institute, Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Kanser Negara | Recruiting | Putrajaya | Putrajaya | 62250 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29623417 | Result | 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. | |
| 28289508 | Result |
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After consented, participants will be randomized into two groups: the intervention group and conventional group during consultation in multidisciplinary clinic.
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| 1 month |
| 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. |
| 27637832 | Result | 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. |
| 35011097 | Result | 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. |
| 31968595 | Result | 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. |
| 29999517 | Result | 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. |
| 35353297 | Result | 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. |
| 41842985 | Derived | Ho CY, Daud ZAM, Mohd Yusof BN, Abdul Majid H, Omar J, Mohd Abas MN, Md Hanapiah S. Perioperative immunonutrition intervention on postoperative outcomes among gynaecological cancer patients under enhanced recovery after surgery setting. Support Care Cancer. 2026 Mar 17;34(4):333. doi: 10.1007/s00520-026-10557-6. |
| 39739975 | Derived | 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. |