Immunonutrition in ERAS Protocols in Gynecologic Oncology

NCT ID: NCT06103526

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2025-08-30

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.

Detailed 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.

Conditions

Nutritional Deficiency; Gynecologic Cancer; ERAS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immunonutrition and ERAS

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.

Group Type: ACTIVE_COMPARATOR

Immunonutrition

Intervention Type: DIETARY_SUPPLEMENT

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

ERAS without immunonutrition

Typical ERAS protocol will be followed for patients in that group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Immunonutrition

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Nikolaos Thomakos

Associate Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikolaos Thomakos, Pf

Role: STUDY_DIRECTOR

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

Locations

First department of Obstetrics and Gynecology

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Nikolaos Thomakos, MD

Role: CONTACT

thomakir@hotmail.com

+302132162291

Facility Contacts

Vasilios Pergialiotis, MD

Role: primary

pergialiotis@yahoo.com

+306947326459

References

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.

Reference Type: BACKGROUND

PMID: 29238571 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27227930 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28468890 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32684485 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30877144 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37086524 (View on PubMed)

Other Identifiers

1233456

Identifier Type: -

Identifier Source: org_study_id