Immunonutrition in ERAS Protocols in Gynecologic Oncology (NUTRIGO)

National and Kapodistrian University of Athens

Status: Enrolling

Conditions: ERAS; Gynecologic Cancer; Nutritional Deficiency

Treatments: Dietary Supplement: Immunonutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT06103526

1233456

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Immunonutrition and ERAS

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Immunonutrition

ERAS without immunonutrition

No Intervention group

Description:

Typical ERAS protocol will be followed for patients in that group