Evaluating frailty and quality of life in women with ovarian cancer undergoing surgery
Official title: Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer (FOLERO) : A Prospective Cohort Study to Determine the Effect of Frailty on Survival and to Assess Early Reversal of Temporary Intestinal Stoma
Run by Karolinska University Hospital · NCT06298877 · Data updated 2026-11-12
This study is testing how frailty affects survival and quality of life in women with advanced ovarian cancer who are having surgery, while also looking at different ways to measure frailty and the safety of certain surgical procedures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 475 (estimated) |
| Sponsor | Karolinska University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Stockholm, Solna and 3 other locations) |
| Status | Recruiting |
| Started | March 11, 2024 |
| Main results expected | March 28, 2030 |
| Study ends | March 28, 2031 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT06298877 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with epithelial ovarian cancer scheduled for cytoreductive surgery.
✕Probably not a fit
Patients who do not have ovarian cancer or those unable to understand Swedish or English may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the impact of frailty on survival outcomes in women with advanced ovarian cancer who are scheduled for cytoreductive surgery. It will evaluate three different frailty assessment tools to determine their predictive value for overall survival. Additionally, the study will explore the feasibility and safety of early reversal of temporary defunctioning stomas in select patients. The research will also investigate the effects of surgical extent and sarcopenia on postoperative outcomes and quality of life.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for surgical treatment and better postoperative outcomes for women with ovarian cancer.
How similar studies have gone: Other studies have shown success in using frailty assessments to predict surgical outcomes, making this approach both relevant and promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with epithelial ovarian cancer scheduled for cytoreductive surgery with curative intent * Age ≥18 years * Signed written informed consent Exclusion Criteria: * Not able to understand the Swedish or English language * Other diagnosis than ovarian cancer on final pathology
Where it's running
-
Karolinska University Hospital
Stockholm, Solna, Sweden Recruiting -
Sahlgrenska University Hospital and Sahlgrenska Academy
Gothenburg, Sweden Recruiting -
Linköping University Hospital
Linköping, Sweden Recruiting -
Skåne University Hospital
Lund, Sweden Recruiting
Study contacts
- Study coordinator: Fihima M Yusuf, MSc
- Email: fihima.mohamed-yusuf@regionstockholm.se
- Phone: +46725815883
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.