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Enrolling by invitation NCT07058753

Prehabilitation in Ovarian Cancer Patients During Chemiotherapy Before Cytoreductive Surgery.

No phase Interventional Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prehabilitation. An intensive prehabilitation for NACT patients.
Who it may be relevant to
Registry conditions: Ovarian Cancer. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

An Intense Course of Prehabilitation in Ovarian Cancer Patients During Neoadjuvant Treatment Awaiting for Interval Debulking Surgery. PREHONED - a Prospective, Randomized, Multicentre Clinical Study.

Overview

Prehabilitation includes care for patients preparing for surgery. This is a modern approach aimed at increasing the patient's functional capacity before surgery and improving postoperative results. Prehabilitation includes preoperative physical activity, nutritional intervention, psychological support, cessation of stimulants and optimization of laboratory test results. Many studies have shown a positive effect of prehabilitation on postoperative results, mainly reducing the number of postoperative complications and shortening the hospitalization time. The assumed time of prehabilitation is 2-6 weeks, but in the case of oncology patients, the procedure should not be delayed only for the sake of prehabilitation. Our study includes oncology patients with ovarian cancer who are referred for neoadjuvant chemotherapy before interval cytoreductive surgery. The assumption of the study is an intensive course of prehabilitation during neoadjuvant treatment, which should provide significantly better postoperative results.

Interventions

  • Procedure Prehabilitation. An intensive prehabilitation for NACT patients
    Patients referred to NACT (neoadjuvant chemotheraphy) for advanced ovarian cancer will undergo an intensive course of prehabilitation including physical exercise, a high-protein diet, protein and vitamin supplementation, optimization of laboratory test results, and psychological support will be provided.

Primary outcome measures

  • Frequency of postoperative complications [Time frame: from surgery for the next 30 days]
  • Length of hospital stay [Time frame: from surgery to hospital discharge (assessed up to 14 days)]
  • Time to start adjuvant chemotherapy [Time frame: from discharge from hospital for the next 2 months]
Secondary outcome measures (2)
  • Progression-free survival [Time frame: From the time of the operation for the next 3 and 5 years]
  • Overall survival [Time frame: From the time of the operation for the next 3 and 5 years]

Eligibility criteria

Inclusion criteria

  • Patients with confirmed ovarian cancer
  • No possibility of performing primary debulking surgery (Fagotti score > 8 points). Referral patient for neoadjuvant chemotherapy
  • Consent to participate in the study
  • Age over 18 years

Exclusion criteria

  • Performing primary debulking surgery
  • Lack of consent to participate in the study
  • Aletti score < 4 points in interval debulking surgery
  • Severe neurological/psychiatric disorders that make contact with the patient difficult

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
Open label
Primary purpose
Prevention

Study locations

Poland · 1 center
  • Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Cente — Katowice

Identifiers

NCT: NCT07058753 · PREH/2025-2-1 · PREH/2025-2-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗