Prehabilitation in Ovarian Cancer Patients During Chemiotherapy Before Cytoreductive Surgery.

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Frequency of postoperative complications [Срок оценки: from surgery for the next 30 days]
• Length of hospital stay [Срок оценки: from surgery to hospital discharge (assessed up to 14 days)]
• Time to start adjuvant chemotherapy [Срок оценки: from discharge from hospital for the next 2 months]

Вторичные конечные точки (2)

• Progression-free survival [Срок оценки: From the time of the operation for the next 3 and 5 years]
• Overall survival [Срок оценки: From the time of the operation for the next 3 and 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Польша · 1 центр

• Department of Gynecology, Obstetrics and Gynecological Oncology, University Clinical Cente — Katowice

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗