Evaluating frailty and quality of life in women with ovarian cancer undergoing surgery
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Karolinska University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Stockholm, Solna and 3 other locations) |
| Trial ID | NCT06298877 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with epithelial ovarian cancer scheduled for cytoreductive surgery.
Not a fit: Patients who do not have ovarian cancer or those unable to understand Swedish or English may not benefit from this study.
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 performed: Other studies have shown success in using frailty assessments to predict surgical outcomes, making this approach both relevant and promising.
Eligibility criteria
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 this trial is running
Stockholm, Solna and 3 other locations
- Karolinska University Hospital — Stockholm, Solna, Sweden (Recruiting)
- Sahlgrenska University Hospital and Sahlgrenska Academy — Gothenburg, Sweden (Not_yet_recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Skåne University Hospital — Lund, Sweden (Not_yet_recruiting)
Study contacts
- Study coordinator: Fihima M Yusuf, MSc
- Email: fihima.mohamed-yusuf@regionstockholm.se
- Phone: +46725815883
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.