Immunonutrition in ERAS Protocols in Gynecologic Oncology

Gynecologic Cancer Clinical Trial

— NUTRIGO  

Official title:

Immunonutrition and Enhanced Recovery After Surgery Protocols in Gynecologic Oncology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06103526
• Other study ID #: 1233456
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: August 30, 2025

Study information

• Verified date: March 2024
• Source: National and Kapodistrian University of Athens
• Contact: Nikolaos Thomakos, MD
• Phone: +302132162291
• Email: thomakir[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A patient with oncological pathology of any type because of impaired digestion and nutrient absorption, decreased intake, and increased nutrition requirements has an increased risk of malnutrition and moderate to severe weight loss.In the present study the investigators will evaluate the impact of perioperative immunonutrition supplementation on the postoperative outcomes.

Description:

Malnutrition has a major effect not only on the postoperative course of cancer surgery but can also complicate or even limit administration or compromise the effectiveness of other treatments such as chemotherapy or radiotherapy in the perioperative period. Immunonutrition is a type of artificial nutrition based on the use of some types of macro- or micronutrients.The purpose of this review was to evaluate the use, indications, and effects of these formulas in oncologic surgical patients in real time and to identify the types of patients who can benefit from enteral immunonutrition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• women with any gynaecologic malignancy enrolled in surgical list of our institute

• must be able to consume oral supplements.

Exclusion Criteria:

• women that are not able to follow ERAS protocol due to medical reasons

• patients with severe disease that cannot compromise with protocol

Related Conditions & MeSH terms

• ERAS
• Gynecologic Cancer
• Malnutrition
• Nutritional Deficiency

Intervention

Dietary Supplement:
• Immunonutrition
enteral supplementation with high amount of proteins, arginine, glutamine, nonessential fatty acids, branched chain fatty acids, nucleotides, or RNA

Locations

Country	Name	City	State
Greece	First department of Obstetrics and Gynecology	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (6)

Fiorindi C, Cuffaro F, Piemonte G, Cricchio M, Addasi R, Dragoni G, Scaringi S, Nannoni A, Ficari F, Giudici F. Effect of long-lasting nutritional prehabilitation on postoperative outcome in elective surgery for IBD. Clin Nutr. 2021 Mar;40(3):928-935. doi: 10.1016/j.clnu.2020.06.020. Epub 2020 Jul 1. — View Citation

Gupta R, Senagore A. Immunonutrition within enhanced recovery after surgery (ERAS): an unresolved matter. Perioper Med (Lond). 2017 Dec 11;6:24. doi: 10.1186/s13741-017-0080-5. eCollection 2017. — View Citation

Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704. — View Citation

Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15. — View Citation

Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21. — View Citation

Yeung SE, Hilkewich L, Gillis C, Heine JA, Fenton TR. Protein intakes are associated with reduced length of stay: a comparison between Enhanced Recovery After Surgery (ERAS) and conventional care after elective colorectal surgery. Am J Clin Nutr. 2017 Jul;106(1):44-51. doi: 10.3945/ajcn.116.148619. Epub 2017 May 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative infections	We will notice possible surgical site infections,respiratory inflammations etc and calculate inflammatory markers and the concentration of white blood cells	Postoperatively (30 days)
Primary	Duration of hospitalization	From date of hospitalization until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.	Until discharge from hospital
Secondary	Postoperative mobilization	From date of surgery until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.	Until first day of mobilization
Secondary	Postoperative morbidity (other than infectious)	Major events such as pulmonary embolism,accuse myocardial infarction,etc	30 days
Secondary	Recurrence rates	Recurrent disease will be monitored through 3 year of follow up	3 years follow-up
Secondary	Overall survival	Overall survival of the patients will be measured through 3 year of follow up	3 years follow-up