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AzTrials

Gynecological CancerPING-ERASNCT06039306

Perioperative Immunonutrition Under Enhanced Recovery After Surgery

A study testing Immunonutrition oral nutrition supplementation in people with Gynecological Cancer and Elective Surgery, run by Universiti Putra Malaysia at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Gynecological Cancer, Elective Surgery
What is being tested?
Immunonutrition oral nutrition supplementation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteMalaysia
Study dates
1 Sep 2024to 30 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

ChiouYi Ho contact

0388925555 ext. 3404

agneshcy0326@gmail.com

Zulfitri 'Azuan Mat Daud contact

zulfitri@upm.edu.my

Malaysia1 site, 1 recruiting

  • Institut Kanser Negara

    Putrajaya, Putrajaya, 62250

    ChiouYi Ho, 0127603622, agneshcy0326@gmail.com

    Recruiting

Other trials in Malaysia

About this study

Official title: Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery

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.

Read the 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.

Being tested
Immunonutrition oral nutrition supplementation
Keywords
gynecological cancer, elective surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immunonutrition oral nutrition supplementationDietary supplement

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

Study groups in NCT06039306
Study groupRoleWhat they receive
interventionExperimentalParticipants 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.
Receives: Dietary Supplement: Immunonutrition oral nutrition supplementation
conventionalNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. daily energy and protein intake

    24-hours diet recall

    Measured: 1 month

  2. body composition

    body composition analyzer; weight in kg; fat free mass in kg; fat mass in kg; muscle mass in kg; height in meter

    Measured: 1 month

  3. immunoglobulin level

    Concentration of immunoglobulin G; Concentration of immunoglobulin A; Concentration of immunoglobulin M

    Measured: 1 month

  4. C-reactive protein

    Concentration of C-reactive protein

    Measured: 1 month

  5. postoperative outcomes

    length of hospitalization

    Measured: 1 months

Secondary outcomes (2)

  1. Functional status

    handgrip strength in kg via Jammar dynamometer

    Measured: 1 month

  2. stress level

    questionnaire 10-item perceived stress scale (PSS-10) form

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2023
  2. Study start1 Sep 2024
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion30 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
After consented, participants will be randomized into two groups: the intervention group and conventional group during consultation in multidisciplinary clinic.
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06039306
Sponsor's protocol ID
RSCH ID-22-04215-WHE
Acronym
PING-ERAS
Status last verified
Aug 2024
First submitted
24 Aug 2023
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 41842985

  • 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.

    PubMed 39739975

Questions about this trial

What is this clinical trial studying?

A study testing Immunonutrition oral nutrition supplementation in people with Gynecological Cancer and Elective Surgery, run by Universiti Putra Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ChiouYi Ho (0388925555 ext. 3404, agneshcy0326@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

daily energy and protein intake (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06039306, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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