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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Complete macroscopic surgical resection (CMR) requires extensive surgery and combined with chemotherapy confers best chance of survival in advanced ovarian cancer. During cytoreductive surgery 11% of women require a temporary diverting intestinal stoma. Unexpectedly, our results from a unique fully accounted for population demonstrate that survival was not improved when increasing the proportion of women in whom CMR was achieved and in a yet unidentified subgroup of women extensive surgery was detrimental. In these women surgical treatment should be omitted in favor of chemotherapy only. Accordingly, there is an imperative need to improve patient selection to surgical treatment. In Sweden, we treat an unselected population of women in a public healthcare system, where 30% of women with are \>75 years. Despite these circumstances guidelines on patient-selection are lacking. Age is an imprecise variable to base clinical decisions on but must be considered with an aging population. The dynamics between physiological changes of aging, comorbidity and medical condition are included in the concept of frailty, that has gained little attention in oncology, despite their potential to stratify risk and mortality. The FOLERO study is a prospective adequately powered national cohort study with aim to determine if frailty instruments may be used to select patient to surgical treatment. In addition, we test the feasibility of early stoma reversal after index cytoreductive surgery in a small phase I trial and follow our patients Health Related Quality of Life after state of the art surgical treatment.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Women with epithelial ovarian cancer scheduled for cytoreductive surgery with curative intent

• Age ≥18 years

• Signed written informed consent

Locations
Other Locations
Sweden
Sahlgrenska University Hospital and Sahlgrenska Academy
NOT_YET_RECRUITING
Gothenburg
Linköping University Hospital
RECRUITING
Linköping
Skåne University Hospital
NOT_YET_RECRUITING
Lund
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Fihima M Yusuf, MSc
fihima.mohamed-yusuf@regionstockholm.se
+46725815883
Time Frame
Start Date: 2024-03-11
Estimated Completion Date: 2029-03-28
Participants
Target number of participants: 450
Treatments
Experimental: Frailty
Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools
Related Therapeutic Areas
Sponsors
Leads: Sahar Salehi

This content was sourced from clinicaltrials.gov