Perioperative Immunonutrition Under Enhanced Recovery After Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunonutrition oral nutrition supplementation.
- Who it may be relevant to
- Registry conditions: Gynecological Cancer, Elective Surgery. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery
Overview
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.
Interventions
- Dietary supplement Immunonutrition oral nutrition supplementation
Participant will prescribed with 2 servings of immunonutrition supplement 5 days before surgery and 7 days after surgery
Primary outcome measures
- daily energy and protein intake [Time frame: 1 month]
- body composition [Time frame: 1 month]
- immunoglobulin level [Time frame: 1 month]
- C-reactive protein [Time frame: 1 month]
- postoperative outcomes [Time frame: 1 months]
Secondary outcome measures (2)
- Functional status [Time frame: 1 month]
- stress level [Time frame: 1 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Malaysia · 1 center
- Institut Kanser Negara — Putrajaya
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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. PMID 41842985
Identifiers
NCT: NCT06039306 · RSCH ID-22-04215-WHE