Prehabilitation within ERAS for gynecologic oncology surgery
Official title: Prehabilitation With Exercise and Immunonutrition (Ocoxin®) in the Perioperative Management of Gynecologic Malignancies Under ERAS Protocol.
Run by Aristotle University Of Thessaloniki · NCT07210164 · Data updated 2026-11-12
This trial tests whether a pre-surgery program of tailored exercise, immunonutrition (Ocoxin), breathing exercises and psychological support combined with ERAS helps people having gynecologic cancer surgery recover faster and with fewer complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 1 site (Thessaloniki) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 30, 2029 |
| Study ends | December 30, 2029 |
| Registry record updated | October 7, 2025 |
| Trial ID | NCT07210164 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–85 with endometrial, ovarian, or cervical cancer planned for laparotomy who are ASA I–III, speak Greek, and consent to ERAS and study participation are ideal candidates.
✕Probably not a fit
Patients with poor functional status (ECOG >2 or ASA >III), those not undergoing laparotomy, or those unable to provide informed consent or follow the Greek-language program are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants scheduled for open gynecologic cancer surgery (laparotomy) will be offered a multifactorial prehabilitation program delivered before operation alongside the hospital's Enhanced Recovery After Surgery (ERAS) pathway. The program includes structured self-guided exercise, immunonutrition (Ocoxin), respiratory training and psychological preparation. Outcomes include quality of life, days in hospital, immediate and 40-day postoperative complications graded by the Clavien-Dindo system, readmission rates, and postoperative morbidity and mortality. The study compares implementation of the prehabilitation protocol versus non-implementation in eligible patients at the participating center.
Why it matters
Potential benefit: If successful, this approach could shorten hospital stays, lower complication and readmission rates, and improve post-surgery quality of life for women having gynecologic cancer operations.
How similar studies have gone: ERAS protocols have repeatedly improved recovery in gynecologic surgery and prehabilitation has shown benefit in other surgical specialties, but multifactorial prehabilitation with immunonutrition in gynecologic oncology remains less well-studied.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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General Hospital of Papageorgiou
Thessaloniki, Greece Recruiting
Study contacts
- Principal investigator: Panagiotis M. Tzitzis, MD, MSc — PhD (c) 1st Department of Obstetrics - Gynaecology Aristotel University of Thessaloniki
- Study coordinator: Dimitrios Tsolakidis C. MD, PhD, Professor OB&GYN
- Email: dtgyn@auth.gr
- Phone: +30 2313 32 3380
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.