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NCT Number: NCT06039306

Perioperative Immunonutrition 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.

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Key information

Conditions

Gynecological Cancer Elective Surgery

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Kanser Negara

Putrajaya, 62250, Malaysia

Location status: Recruiting

Location contact

ChiouYi Ho

CONTACT

[email protected]

0127603622

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunonutrition oral nutrition supplementation

Dietary Supplement

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

Primary outcomes

  1. daily energy and protein intake

    Time frame: 1 month

    24-hours diet recall

  2. body composition

    Time frame: 1 month

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

  3. immunoglobulin level

    Time frame: 1 month

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

  4. C-reactive protein

    Time frame: 1 month

    Concentration of C-reactive protein

  5. postoperative outcomes

    Time frame: 1 months

    length of hospitalization

Secondary outcomes

  1. Functional status

    Time frame: 1 month

    handgrip strength in kg via Jammar dynamometer

  2. stress level

    Time frame: 1 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

ChiouYi Ho

CONTACT

[email protected]

0388925555 ext. 3404

Zulfitri 'Azuan Mat Daud

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery

Acronym: PING-ERAS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2023
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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