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

Official title

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

Overview

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.

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, s
• 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

Primary outcome measures

• Postoperative morbidity [Time frame: Up to the 30th post operative day]
• Duration of hospitalization [Time frame: Until the patient discharged (assessed up to 4 days)]
• General Quality of Life (QoL) [Time frame: Up to the time of discharge (assessed up to 4 days)]

Secondary outcome measures (6)

• Time interval between the onset of adjuvant anti-neoplastic therapy [Time frame: Up to 120 days after surgery]
• Hospital readmission at 90 days [Time frame: Up to the 90th postoperative day]
• Cachexia [Time frame: Up to the time of discharge (assessed up to 5 days)]
• Sexual Health [Time frame: Up to the time of discharge (assessed up to 4 days)]
• Quality of Life in ovarian cancer [Time frame: Up to the time of discharge (assessed up to 4 days)]
• Quality of Life in endometrial cancer [Time frame: Up to the time of discharge (assessed up to 4 days)]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Greece · 1 center

• General Hospital of Papageorgiou — Thessaloniki

Publications

• 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
• 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
• 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
• 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 PMID 32826114
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07210164 · 337/2025, 18.09.2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗