Trials / Recruiting

RecruitingNCT07210164

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

Prehabilitation With Exercise and Immunonutrition (Ocoxin®) in the Perioperative Management of Gynecologic Malignancies Under ERAS Protocol.

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 100 (estimated)

Sponsor: Aristotle University Of Thessaloniki · Academic / Other
Sex: Female
Age: 18 Years – 85 Years
Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to investigate the impact of multifactorial preoperative empowerment (pre-habilitation protocol) on patients with gynecological cancer who undergo oncological surgery. The objective of this study is to demonstrate whether the implementation of pre-habilitation program empowerment as opposed to its non-implementation leads to an improvement in quality of life, a reduction in days of hospitalization, a reduction in immediate (up to discharge) and long term (up to 40th post-surgery day) postoperative complications (as measured with the Clavien Dindo system), a reduction in hospital readmission rates, and postoperative morbidity and mortality.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2025-12-01
Primary completion: 2029-12-30
Completion: 2029-12-30
First posted: 2025-10-07
Last updated: 2025-10-07

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT07210164. Inclusion in this directory is not an endorsement.