Perioperative Immunonutrition Under Enhanced Recovery After Surgery

NCT ID: NCT06039306

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-10-30

Brief Summary

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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:

* 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

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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.

Conditions

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Gynecological Cancer Elective Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Immunonutrition oral nutrition supplementation

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Immunonutrition oral nutrition supplementation

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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ChiouYi Ho

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ChiouYi Ho

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Malaysia

Locations

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Institut Kanser Negara

Putrajaya, Putrajaya, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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ChiouYi Ho

Role: CONTACT

0388925555 ext. 3404

Zulfitri 'Azuan Mat Daud

Role: CONTACT

Facility Contacts

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ChiouYi Ho

Role: primary

0127603622

References

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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.

Reference Type BACKGROUND
PMID: 29623417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28289508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27637832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35011097 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31968595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29999517 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35353297 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39739975 (View on PubMed)

Other Identifiers

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RSCH ID-22-04215-WHE

Identifier Type: -

Identifier Source: org_study_id

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