Prehabilitation in Gynaecological Cancer Patients

Recruiting now · Phase 3

Conditions studied: Ovarian Cancer, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Endometrial Cancer, Frailty

In brief

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.

Key facts

Study ID

NCT04789694

Run by

Charles University, Czech Republic

People needed

64

Starts

2021-01-25

Expected to finish

2026-06-30

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Second malignant tumour (under the treatment)
• Patient is not suitable for any surgery delay
• Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk

Where it is running

• Gynecologic Oncology Center in Prague — Prague, Czechia (enrolling)

Full record on ClinicalTrials.gov

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