Improving resilience in gynaecological cancer patients before surgery
Prehabilitation in Patients With Gynaecological Cancer Planned for Postponed Surgical Management: A Prospective Randomised Trial.
This study is testing whether a special program that includes exercise, mental support, and nutrition can help women with advanced ovarian and frail endometrial cancer feel better and recover faster before their surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Charles University, Czech Republic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Prague) |
| Trial ID | NCT04789694 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced ovarian cancer not suitable for primary surgery and frail patients with early-stage endometrial cancer.
Not a fit: Patients who are not physically able to participate in the prehabilitation program or those with second malignant tumors will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes and quality of life for patients undergoing surgery for gynaecological cancers.
How similar studies have performed: While multimodal prehabilitation has shown positive effects in non-gynaecological cancer patients, this specific approach in gynaecological cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Prague
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.