Pre-habilitation Within ERAS Protocol for Gynecologic Oncology Surgery: The Pre_ERAS Study

Summary

ERAS (Enhanced Recovery After Surgery) protocols are step-by-step care plans that help patients recover faster after surgery. They focus on keeping the body's normal functions, lowering stress from surgery, and supporting a quicker recovery. In gynecologic cancer surgeries, ERAS has been shown to help patients do better, have fewer problems, and leave the hospital sooner.

A prehabilitation program, in combination with ERAS protocols, aims to optimize patients' physical and psychological condition prior to surgery for gynecological cancers. Interventions may include tailored exercise, nutritional support, respiratory training, and psychological preparation. By enhancing baseline fitness and resilience, prehabilitation improves the body's ability to tolerate surgical stress, reduces complications, and facilitates a faster, smoother recovery within the ERAS framework.

Conditions

• ERAS
• Compliance
• Quality of Life (QOL)
• Excercise
• Immunonutrition
• Post Operative Pain
• Laparotomy Patients
• Surgical Complication
• Gynaecological Malignancies
• Gynaecologic Cancer
• Gynaecological Oncology

Interventions

DIETARY_SUPPLEMENT

Ocoxin

Food Supplement based on Amino Acids, Plants, Vitamins and Minerals. Composition: Maltodextrin, L-Arginine, L-Cysteine, Microcrystalline cellulose, Talcum, Vitamin C (L-ascorbic acid), Zinc sulfate, Green Tea Extract (Camellia sinensis (L.) Kuntze), Manganese sulphate, Extracto de Canela (Cinnamomum verum J. Presl.), Vitamin B6 (pyridoxine hydrochloride). Ocoxin utilizes Catalysis' Molecular Activation Technology (MAT) to enhance the biological activity of its natural antioxidant ingredients, such as green tea polyphenols (EGCG), to increase their antitumoral and immunomodulatory effects. This patented technology is applied to boost the efficacy of compounds within Ocoxin, such as EGCG, enabling them to exert more potent effects on cancer cells by inducing apoptosis, inhibiting tumor growth and metastasis, and supporting the body's immune response.

PROCEDURE

Structured self-guided exercise

The patient exercises in a structured manner with the help of a relevant interactive form/guide and simple aids (e.g. chair, step, water bottle, broomstick) by performing six categories of exercises: 1. Breathing exercises, 2. Pelvic floor exercises-pelvic mobility, 3. Upper trunk exercises, 4. Lower trunk exercises, 5. Aerobic exercises, 6. Stretching exercises, at a predetermined pace (number of repetitions) of each exercise and a limit of not exceeding the value 5-6 on the ten-point modified Borg fatigue scale. The intern records her activity on a form-"exercise log". The recommendation is the maximum implementation of the exercise program but in any case not less than 3 times a week.

Sponsors & Collaborators

• Catalysis SL

  collaborator INDUSTRY

• Aristotle University Of Thessaloniki

  lead OTHER

Principal Investigators

• Dimitrios C. Tsolakidis, MD, PhD · Professor of Obstetrics - Gynaecology, Aristotel University of Thessaloniki

• Panagiotis M. Tzitzis, MD, MSc · PhD (c) 1st Department of Obstetrics - Gynaecology Aristotel University of Thessaloniki

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2029-12-30

Completion

2029-12-30

Countries

• Greece

Study Locations