Clinical trial Recruiting at 4 sites Interventional Ages 18 and up Women only

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.

More Ovarian Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment475 (estimated)
SponsorKarolinska University Hospital
Academic / other
Drugs / interventionschemotherapy
Locations4 sites (Stockholm, Solna and 3 other locations)
StatusRecruiting
StartedMarch 11, 2024
Main results expectedMarch 28, 2030
Study endsMarch 28, 2031
Registry record updatedSeptember 28, 2026
Trial IDNCT06298877 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

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.