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Immunonutrition in ERAS Protocols in Gynecologic Oncology

Immunonutrition and Enhanced Recovery After Surgery Protocols in Gynecologic Oncology

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06103526
Acronym
NUTRIGO
Enrollment
200
Registered
2023-10-26
Start date
2023-10-18
Completion date
2025-08-30
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ERAS, Gynecologic Cancer, Nutritional Deficiency

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.

Interventions

DIETARY_SUPPLEMENTImmunonutrition

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

Sponsors

National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Perioperative infectionsPostoperatively (30 days)We will notice possible surgical site infections,respiratory inflammations etc and calculate inflammatory markers and the concentration of white blood cells
Duration of hospitalizationUntil discharge from hospitalFrom date of hospitalization until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.

Secondary

MeasureTime frameDescription
Postoperative mobilizationUntil first day of mobilizationFrom date of surgery until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.
Postoperative morbidity (other than infectious)30 daysMajor events such as pulmonary embolism,accuse myocardial infarction,etc
Recurrence rates3 years follow-upRecurrent disease will be monitored through 3 year of follow up
Overall survival3 years follow-upOverall survival of the patients will be measured through 3 year of follow up

Countries

Greece

Contacts

Primary ContactNikolaos Thomakos, MD
thomakir@hotmail.com+302132162291

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026