Improving resilience in gynaecological cancer patients before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of multimodal prehabilitation, which includes physical activity, psychological support, and nutritional guidance, in enhancing the functional capacity and quality of life of patients with gynaecological cancers before surgery. Sixty-four patients will be randomly assigned to either a control group receiving standard care or an active group undergoing the prehabilitation program. The study aims to assess the impact of these interventions on postoperative recovery and overall well-being. It focuses on patients with advanced ovarian cancer and frail endometrial cancer patients scheduled for surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Gynecologic Oncology Center in Prague
  Prague, Czechia Recruiting

Study contacts

• Principal investigator: David Cibula, prof. — Charles University, Czech Republic
• Study coordinator: Jana Stribrna
• Email: jana.stribrna@vfn.cz
• Phone: +420 224 967 432

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.