Clinical trial NCT06039306: Perioperative Immunonutrition Under Enhanced Recovery After Surgery
Official title: Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gynecological Cancer
Elective Surgery
Keywords: gynecological cancer, elective surgery
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After consented, participants will be randomized into two groups: the intervention group and conventional group during consultation in multidisciplinary clinic.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: daily energy and protein intake
timeFrame: 1 month
measure: body composition
timeFrame: 1 month
measure: immunoglobulin level
timeFrame: 1 month
measure: C-reactive protein
timeFrame: 1 month
measure: postoperative outcomes
timeFrame: 1 months
Secondary outcomes:
measure: Functional status
timeFrame: 1 month
measure: stress level
timeFrame: 1 month
Other outcomes:
Locations:
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara (National Cancer Institute)
Study officials:
affiliation: National Cancer Institute, Malaysia
name: ChiouYi Ho
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.