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

NCT07210164 | Recruiting

• 1 other identifier: 337/2025, 18.09.2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prehabilitation; ERAS; Gynecologic Cancers; Immunonutrition

Outcome Measures

Primary Outcomes (3)

• Postoperative morbidity

  Systematic recording of complications based on the Clavien Dindo system, during hospitalization and in the immediate postoperative period (up to the 30th postoperative day).

  Up to the 30th post operative day

• Duration of hospitalization

  The discharge day is defined as the postoperative day on which the following criteria are met in their entirety: 1. adequate mobilization, 2. tolerance of solid foods and adequate oral water intake, 3. adequate analgesia only with oral analgesics, 4. mobilization of intestinal function / flatus, 5. Absence of Clavien Dindo \>II complication.

  Until the patient discharged (assessed up to 4 days)

• General Quality of Life (QoL)

  Use of metric tools: structured and weighted questionnaires in Greek language EORTC QLQ-C30 (version 3.0) (general quality of life). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

  Up to the time of discharge (assessed up to 4 days)

Secondary Outcomes (6)

• Time interval between the onset of adjuvant anti-neoplastic therapy

  Up to 120 days after surgery

• Hospital readmission at 90 days

  Up to the 90th postoperative day

• Cachexia

  Up to the time of discharge (assessed up to 5 days)

• Sexual Health

  Up to the time of discharge (assessed up to 4 days)

• Quality of Life in ovarian cancer

  Up to the time of discharge (assessed up to 4 days)

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

This group undergo a structured preoperative self-guided exercise protocol (consisting of mild physical activity with a defined exercise program, respiratory exercise, muscle strengthening), immunonutrition (Ocoxin©) and usual clinical practice (stopping alcohol, regulating anemia and glucose levels). During the period of hospitalatization adhere to the 21-point ERAS protocol .

Dietary Supplement: Ocoxin; Procedure: Structured self-guided exercise

Control group

NO INTERVENTION

This group follow the usual clinical practice (stopping alcohol, regulating anemia and glucose levels). During the period of hospitalatization adhere to the 21-point ERAS protocol .

Interventions

Ocoxin DIETARY_SUPPLEMENT

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.

Prehabilitation group

Structured self-guided exercise PROCEDURE

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.

Prehabilitation group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type of gynecological malignancy: endometrial cancer, ovarian cancer, cervical cancer, treated with laparotomy after the decision of the gynecological-oncology unit (positive opinion of the Multidisciplinary Tumor Board - MDT)
• Patient age: 18 to 85 years
• General condition of the patient: ASA score I-III
• Consent to implement the accelerated recovery protocol - Enhanced recovery after surgery (ERAS)
• Sufficient understanding of the Greek language
• Provision of signed, after thorough information, consent to participate in the study

You may not qualify if:

• Women with performance status: ECOG \>2 and ASA score \>III
• Women who have not been informed and have given written consent

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Catalysis SL: collaborator

Study Sites (1)

General Hospital of Papageorgiou

Thessaloniki, 56429, Greece

RECRUITING

Related Publications (14)

• Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.

  PMID: 26603969 BACKGROUND

• Miralpeix E, Mancebo G, Gayete S, Corcoy M, Sole-Sedeno JM. Role and impact of multimodal prehabilitation for gynecologic oncology patients in an Enhanced Recovery After Surgery (ERAS) program. Int J Gynecol Cancer. 2019 Oct;29(8):1235-1243. doi: 10.1136/ijgc-2019-000597. Epub 2019 Aug 30.

  PMID: 31473663 BACKGROUND

• Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.

  PMID: 26757238 BACKGROUND

• Hubner M, Kusamura S, Villeneuve L, Al-Niaimi A, Alyami M, Balonov K, Bell J, Bristow R, Guiral DC, Fagotti A, Falcao LFR, Glehen O, Lambert L, Mack L, Muenster T, Piso P, Pocard M, Rau B, Sgarbura O, Somashekhar SP, Wadhwa A, Altman A, Fawcett W, Veerapong J, Nelson G. Guidelines for Perioperative Care in Cytoreductive Surgery (CRS) with or without hyperthermic IntraPEritoneal chemotherapy (HIPEC): Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations - Part II: Postoperative management and special considerations. Eur J Surg Oncol. 2020 Dec;46(12):2311-2323. doi: 10.1016/j.ejso.2020.08.006. Epub 2020 Aug 13.

  PMID: 32826114 BACKGROUND

• Bisch SP, Jago CA, Kalogera E, Ganshorn H, Meyer LA, Ramirez PT, Dowdy SC, Nelson G. Outcomes of enhanced recovery after surgery (ERAS) in gynecologic oncology - A systematic review and meta-analysis. Gynecol Oncol. 2021 Apr;161(1):46-55. doi: 10.1016/j.ygyno.2020.12.035. Epub 2020 Dec 30.

  PMID: 33388155 BACKGROUND

• Miralpeix E, Fabrego B, Rodriguez-Cosmen C, Sole-Sedeno JM, Gayete S, Jara-Bogunya D, Corcoy M, Mancebo G. Prehabilitation in an ERAS program for endometrial cancer patients: impact on post-operative recovery. Int J Gynecol Cancer. 2023 Apr 3;33(4):528-533. doi: 10.1136/ijgc-2022-004130.

  PMID: 36898697 BACKGROUND

• Ferrero A, Vassallo D, Geuna M, Fuso L, Villa M, Badellino E, Barboni M, Coata P, Santoro N, Delgado Bolton RC, Biglia N. Immunonutrition in ovarian cancer: clinical and immunological impact? J Gynecol Oncol. 2022 Nov;33(6):e77. doi: 10.3802/jgo.2022.33.e77. Epub 2022 Aug 12.

  PMID: 36047379 BACKGROUND

• Prieto I, Montemuino S, Luna J, de Torres MV, Amaya E. The role of immunonutritional support in cancer treatment: Current evidence. Clin Nutr. 2017 Dec;36(6):1457-1464. doi: 10.1016/j.clnu.2016.11.015. Epub 2016 Nov 24.

  PMID: 27931879 BACKGROUND

• 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.

  PMID: 30877144 BACKGROUND

• 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.

  PMID: 37086524 BACKGROUND

• Bisch S, Nelson G, Altman A. Impact of Nutrition on Enhanced Recovery After Surgery (ERAS) in Gynecologic Oncology. Nutrients. 2019 May 16;11(5):1088. doi: 10.3390/nu11051088.

  PMID: 31100877 BACKGROUND

• Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.

  PMID: 27637832 BACKGROUND

• Diaz-Feijoo B, Agusti-Garcia N, Sebio R, Lopez-Hernandez A, Siso M, Glickman A, Carreras-Dieguez N, Fuste P, Marina T, Martinez-Egea J, Aguilera L, Perdomo J, Pelaez A, Lopez-Baamonde M, Navarro-Ripoll R, Gimeno E, Campero B, Torne A, Martinez-Palli G, Arguis MJ. Feasibility of a Multimodal Prehabilitation Programme in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer: A Pilot Study. Cancers (Basel). 2022 Mar 23;14(7):1635. doi: 10.3390/cancers14071635.

  PMID: 35406407 BACKGROUND

• Inci MG, Sehouli J, Schnura E, Lee M, Roll S, Reinhold T, Klews J, Kaufner L, Niggemann P, Groeben H, Toelkes J, Reisshauer A, Liebl M, Daehnert E, Zimmermann M, Knappe-Drzikova B, Rolker S, Nunier B, Algharably E, Pirmorady Sehouli A, Zwantleitner L, Krull A, Heitz F, Ataseven B, Chekerov R, Harter P, Schneider S. The KORE-INNOVATION trial, a prospective controlled multi-site clinical study to implement and assess the effects of an innovative peri-operative care pathway for patients with ovarian cancer: rationale, methods and trial design. Int J Gynecol Cancer. 2023 Aug 7;33(8):1304-1309. doi: 10.1136/ijgc-2023-004531.

  PMID: 37208019 BACKGROUND

MeSH Terms

Conditions

Patient Compliance; Pain, Postoperative

Interventions

Ocoxin

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dimitrios C. Tsolakidis, MD, PhD

  Professor of Obstetrics - Gynaecology, Aristotel University of Thessaloniki

  STUDY CHAIR

• Panagiotis M. Tzitzis, MD, MSc

  PhD (c) 1st Department of Obstetrics - Gynaecology Aristotel University of Thessaloniki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Tsolakidis C. MD, PhD, Professor OB&GYN

CONTACT

+30 2313 32 3380; dtgyn@auth.gr

Panagiotis Tzitzis M. MD, MSc

CONTACT

+30 6946621179; ptzitzis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,MSc

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 7, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)