Status:
RECRUITING
Prehabilitation in Gynaecological Cancer Patients
Lead Sponsor:
Charles University, Czech Republic
Collaborating Sponsors:
University Hospital Ostrava
University Hospital Olomouc
Conditions:
Ovarian Cancer
Ovarian Cancer Stage III
Eligibility:
FEMALE
18-85 years
Phase:
PHASE3
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 p...
Detailed Description
The objective of the trial is to evaluate the impact of intensive multimodal prehabilitation protocol on pre-operative functional capacity, postoperative morbidity, and quality of life in patients und...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04789694
Start Date
January 25 2021
End Date
June 30 2026
Last Update
August 31 2023
Active Locations (1)
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1
Gynecologic Oncology Center in Prague
Prague, Czechia, 12000