Perioperative Immunonutrition Under Enhanced Recovery After Surgery (PING-ERAS)
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ClinicalTrials.gov Identifier: NCT06039306 |
Recruitment Status :
Not yet recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
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Gynecological Cancer Elective Surgery | Dietary Supplement: Immunonutrition oral nutrition supplementation | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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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.
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- daily energy and protein intake [ Time Frame: 1 month ]24-hours diet recall
- 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
- immunoglobulin level [ Time Frame: 1 month ]Concentration of immunoglobulin G; Concentration of immunoglobulin A; Concentration of immunoglobulin M
- C-reactive protein [ Time Frame: 1 month ]Concentration of C-reactive protein
- postoperative outcomes [ Time Frame: 1 months ]length of hospitalization
- Functional status [ Time Frame: 1 month ]handgrip strength in kg via Jammar dynamometer
- stress level [ Time Frame: 1 month ]questionnaire 10-item perceived stress scale (PSS-10) form
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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 |
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
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
Contact: ChiouYi Ho | 0388925555 ext 3404 | agneshcy0326@gmail.com | |
Contact: Zulfitri 'Azuan Mat Daud | zulfitri@upm.edu.my |
Malaysia | |
Institut Kanser Negara (National Cancer Institute) | |
Putrajaya, Malaysia, 62250 | |
Contact: ChiouYi Ho 0127603622 ext 3404 agneshcy0326@gmail.com |
Principal Investigator: | ChiouYi Ho | National Cancer Institute, Malaysia |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
gynecological cancer, elective surgery |