Clinical Trial

Prehabilitation in Gynaecological Cancer Patients

Study acronym: PHOCUS
Recruiting Phase 3
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Record status
This record was last updated March 19, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Prehabilitation refers to interventions aiming to improve patients' resilience and functional capacity before a known stressful event, e.g., scheduled surgery. These interventions usually consist of physical activity and psychological and nutritional support. There is substantial evidence of the positive effect of multimodal prehabilitation among patients treated surgically for non-gynaecological cancers; however, no prospective data are available in gynaecological cancer patients. PHOCUS trial is a prospective randomised trial aiming to evaluate the role of multimodal prehabilitation in patients with gynaecological cancer. Sixty-four patients will be randomised in single institution within 36 months with a 1:1 ratio into ARM A: control arm which will be provided with a basic information and standard of care support; ARM B: active arm undergoing multimodal prehabilitation composed of physical activity and psychological and nutritional support. All patients will be assessed at standard intervals (three times during the trial) by a spectrum of non-invasive tests, evaluating physical functional capacity, postoperative morbidity, nutritional status, level of stress and anxiety, and quality of life.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-03-08; most recent amendment 2026-03-18.
Trial Details
NCT Number NCT04789694
Lead Sponsor Charles University, Czech Republic
Collaborators: University Hospital Ostrava, University Hospital Olomouc, University Hospital Pilsen, The Faculty Hospital Na Bulovce
Conditions Ovarian Cancer, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Endometrial Cancer, Frailty
Enrollment 64 participants
Start Date 2021-01-25
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-19