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Prehabilitation in Gynaecological Cancer Patients

RecruitingPhase 3Ages 18 Years - 85 YearsFemaleCharles University, Czech Republic
NCT04789694 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ph

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📋 Eligibility rules (as published)
Inclusion criteria Two groups of patients will be eligible for the trial: i) Epithelial ovarian cancer patients referred for NACT: a) FIGO stage III or IV disease; b) Patient is not a candidate for primary debulking surgery; c) Patient is a suitable candidate for standard of care combined chemotherapy; d) Patient is a candidate for interval.debulking surgery ii) Stage I or II endometrial cancer patients classifying as frail according to the validated modified Frailty Index: a) FIGO stage I or II; b) Patient is classified as frail; c) Patient is suitable candidate for hormonal therapy. Exclusion criteria 1. Second malignant tumour (under the treatment) 2. Patient is not suitable for any surgery delay 3. Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk
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What it tests

  • Physiological intervention
  • Psychological intervention
  • Nutritional intervention
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Where

1 site
Gynecologic Oncology Center in Prague
Prague, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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