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Perioperative Immunonutrition Under Enhanced Recovery After Surgery (PING-ERAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06039306
Recruitment Status : Not yet recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
ChiouYi Ho, Universiti Putra Malaysia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Gynecological Cancer Elective Surgery Dietary Supplement: Immunonutrition oral nutrition supplementation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery
Estimated Study Start Date : December 1, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 30, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Dietary Supplement: Immunonutrition oral nutrition supplementation
Participant will prescribed with 2 servings of immunonutrition supplement 5 days before surgery and 7 days after surgery
No Intervention: 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06039306


Contacts
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Contact: ChiouYi Ho 0388925555 ext 3404 agneshcy0326@gmail.com
Contact: Zulfitri 'Azuan Mat Daud zulfitri@upm.edu.my

Locations
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Malaysia
Institut Kanser Negara (National Cancer Institute)
Putrajaya, Malaysia, 62250
Contact: ChiouYi Ho    0127603622 ext 3404    agneshcy0326@gmail.com   
Sponsors and Collaborators
Universiti Putra Malaysia
Investigators
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Principal Investigator: ChiouYi Ho National Cancer Institute, Malaysia
More Information
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Publications of Results:

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Responsible Party: ChiouYi Ho, Principal Investigator, Universiti Putra Malaysia
ClinicalTrials.gov Identifier: NCT06039306    
Other Study ID Numbers: RSCH ID-22-04215-WHE
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ChiouYi Ho, Universiti Putra Malaysia:
gynecological cancer, elective surgery