Immunonutrition in ERAS Protocols in Gynecologic Oncology

NCT06103526 | Recruiting

• 1 other identifier: 1233456
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nutritional Deficiency; Gynecologic Cancer; ERAS

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (4)

• Postoperative mobilization

  Until first day of mobilization

• Postoperative morbidity (other than infectious)

  30 days

• Recurrence rates

  3 years follow-up

• Overall survival

  3 years follow-up

Study Arms (2)

Immunonutrition and ERAS

ACTIVE COMPARATOR

Immunonutrition supplements will be provided to patients in the form of oral supplements given twice daily for 3 days pre-surgery and 3 days post-surgery.

Dietary Supplement: Immunonutrition

ERAS without immunonutrition

NO INTERVENTION

Typical ERAS protocol will be followed for patients in that group

Interventions

Immunonutrition DIETARY_SUPPLEMENT

enteral supplementation with high amount of proteins, arginine, glutamine, nonessential fatty acids, branched chain fatty acids, nucleotides, or RNA

Immunonutrition and ERAS

Eligibility Criteria

• Age: 20 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with any gynaecologic malignancy enrolled in surgical list of our institute
• must be able to consume oral supplements.

You may not qualify if:

• women that are not able to follow ERAS protocol due to medical reasons
• patients with severe disease that cannot compromise with protocol

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

First department of Obstetrics and Gynecology

Athens, 11523, Greece

RECRUITING

Related Publications (6)

• 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.

  PMID: 29238571 BACKGROUND

• 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.

  PMID: 27227930 BACKGROUND

• 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.

  PMID: 28468890 BACKGROUND

• 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.

  PMID: 32684485 BACKGROUND

• 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.

  PMID: 30877144 BACKGROUND

• 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.

  PMID: 37086524 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nikolaos Thomakos, Pf

  National Kapodistrian University of Athens,1st obs and gyn department

  STUDY DIRECTOR

Central Study Contacts

Nikolaos Thomakos, MD

CONTACT

+302132162291; thomakir@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 26, 2023
• Study Start: October 18, 2023
• Primary Completion: May 30, 2025
• Study Completion: August 30, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)