NCT04789694 Prehabilitation in Gynaecological Cancer Patients
| NCT ID | NCT04789694 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Charles University, Czech Republic |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2021-01-25 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 64 participants in total. It began in 2021-01-25 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
David Cibula, prof.
PRINCIPAL INVESTIGATOR
Charles University, Czech Republic
Frequently Asked Questions
Who can join the NCT04789694 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 85 Years, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04789694 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 64 participants.
Is NCT04789694 currently recruiting?
Yes, NCT04789694 is actively recruiting participants. Contact the research team at jana.stribrna@vfn.cz for enrollment information.
Where is the NCT04789694 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT04789694 clinical trial?
NCT04789694 is sponsored by Charles University, Czech Republic. The principal investigator is David Cibula, prof. at Charles University, Czech Republic. The trial plans to enroll 64 participants.
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