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Enrolling by Invitation

NCT Number: NCT07058753

Prehabilitation in Ovarian Cancer Patients During Chemiotherapy Before Cytoreductive Surgery.

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Center of the Medical University of Silesia

Katowice, 40-752, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation. An intensive prehabilitation for NACT patients

Procedure

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 outcomes

  1. Frequency of postoperative complications

    Time frame: from surgery for the next 30 days

    Analysis of the incidence of complications, including assessment according to the Clavien-Dindo classification. Analysis of complications will include the incidence of intensive care units hospitalization, frequency of reoperation, dehiscence of intestinal anastomosis, wound dehiscence with eventeration, need for blood transfusion and readmission within 30 days

  2. Length of hospital stay

    Time frame: from surgery to hospital discharge (assessed up to 14 days)

    The analysis will include the length of hospitalization after surgery.

  3. Time to start adjuvant chemotherapy

    Time frame: from discharge from hospital for the next 2 months

    Comparison of time from hospital discharge to start of adjuvant chemotherapy

Secondary outcomes

  1. Progression-free survival

    Time frame: From the time of the operation for the next 3 and 5 years

    Comparison of progression-free survival in both groups at 3 and 5 years of follow-up.

  2. Overall survival

    Time frame: From the time of the operation for the next 3 and 5 years

    Comparison of overall survival in both groups at 3 and 5 years of follow-up

Other outcomes

  1. Quality of life assessment

    Time frame: From study enrollment to surgery (up to 4 months)

    Measuring changes in quality of life during the prehabilitation program. The assessment of quality of life will be performed using the standardized EORTC Quality of Life QLQ-C30 questionnaire. The EORTC QLQ-C30 assesses quality of life in five functional domains (physical, role, cognitive, emotional, and social), three symptom domains (fatigue, pain, nausea and vomiting), a global health status domain (GHS/QoL), and five single-item domains (dyspnoea, insomnia, loss of appetite, constipation and diarrhea, and financial problems due to illness) The higher the score in the functional domains and in the global health status domain, the better the patient's quality of life, while the higher the score in the symptom domain, the worse the quality of life due to the severity of disease-related symptoms.

  2. Depression and anxiety assessment

    Time frame: from study enrollment to surgery (up to 4 months)

    Measuring changes in depression and anxiety during the prehabilitation program. The assessment of depression and anxiety will be performed using the HADS questionnaire. The HADS is a self-report questionnaire, and it consists of 2 subscales designed to identify and quantify anxiety and depression in patients, especially in oncological patients whereas a score of 8 points indicates mild anxiety or depression and the higher the score, the greater the severity of anxiety and depressive disorders.

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study 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.

Acronym: PREHONED

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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