Prehabilitation in Gynaecological Cancer Patients
Launched by CHARLES UNIVERSITY, CZECH REPUBLIC · Mar 8, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The PHOCUS trial is studying how a program called "prehabilitation" can help women with gynecological cancers, like ovarian and endometrial cancer, prepare for surgery. Prehabilitation includes exercises, nutritional advice, and emotional support to improve patients' strength and well-being before their surgery. In this trial, 64 women will be divided into two groups: one group will receive standard care and basic information, while the other will participate in the prehabilitation program. Researchers will check in on all participants at different points during the trial to see how they are doing in terms of physical ability, recovery after surgery, nutrition, stress levels, and overall quality of life.
To join the trial, participants should be women aged between 65 and 74 with specific types of ovarian cancer (stages III or IV) or women with early-stage endometrial cancer who are considered frail. They must be suitable candidates for surgery and chemotherapy. However, those with a second cancer, unable to delay surgery, or not physically capable of following the prehabilitation plan won't be eligible. This study is important because it aims to gather new information specifically for women with gynecological cancers, which hasn't been done before, to help improve their care and recovery.
Gender
FEMALE
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
About Charles University, Czech Republic
Charles University, located in the Czech Republic, is a prestigious institution renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, the university leverages its extensive academic expertise and state-of-the-art facilities to conduct innovative research that aims to improve patient outcomes and contribute to the global medical community. With a focus on ethical standards and rigorous scientific methodologies, Charles University collaborates with various stakeholders to explore new therapies and enhance healthcare practices, fostering a culture of excellence in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Prague, , Czechia
Patients applied
Trial Officials
David Cibula, prof.
Principal Investigator
Charles University, Czech Republic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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