Perioperative Immunonutrition Under Enhanced Recovery After Surgery

Elective Surgery Clinical Trial

— PING-ERAS  

Official title:

Perioperative Immunonutrition Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06039306
• Other study ID #: RSCH ID-22-04215-WHE
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Universiti Putra Malaysia
• Contact: ChiouYi Ho
• Phone: 0388925555
• Email: agneshcy0326[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Elective Surgery
• Gynecological Cancer

Intervention

Dietary Supplement:
• Immunonutrition oral nutrition supplementation
Participant will prescribed with 2 servings of immunonutrition supplement 5 days before surgery and 7 days after surgery

Locations

Country	Name	City	State
Malaysia	Institut Kanser Negara (National Cancer Institute)	Putrajaya

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (7)

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. — View Citation

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, Pre — View Citation

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. 2 — View Citation

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) — View Citation

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. — View Citation

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 resect — View Citation

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 Surgi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daily energy and protein intake	24-hours diet recall	1 month
Primary	body composition	body composition analyzer; weight in kg; fat free mass in kg; fat mass in kg; muscle mass in kg; height in meter	1 month
Primary	immunoglobulin level	Concentration of immunoglobulin G; Concentration of immunoglobulin A; Concentration of immunoglobulin M	1 month
Primary	C-reactive protein	Concentration of C-reactive protein	1 month
Primary	postoperative outcomes	length of hospitalization	1 months
Secondary	Functional status	handgrip strength in kg via Jammar dynamometer	1 month
Secondary	stress level	questionnaire 10-item perceived stress scale (PSS-10) form	1 month