Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer

NCT06298877 | Recruiting

• 1 other identifier: 2023-04696-01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival time is calculated from the date of index surgery to the date of death (due to any cause), or for patients still alive to the date of last follow-up.

  24 months after index surgery

Secondary Outcomes (16)

• 1-year mortality

  12 months from index surgery

• Health related quality of life (HRQoL) (QLQ-C30)

  At baseline, 12-15 weeks after index surgery and 12 months after index surgery

• Health related quality of life (HRQoL) (QLQ-OV28)

  At baseline, 12-15 weeks after index surgery and 12 months after index surgery

• Health related quality of life (HRQoL) (QLQ-ELD14)

  At baseline, 12-15 weeks after index surgery and 12 months after index surgery

• Health related quality of life (HRQoL) (EQ-5D-5L)

  At baseline, 12-15 weeks after index surgery and 12 months after index surgery

Study Arms (1)

Frailty

EXPERIMENTAL

Single arm study evaluating frailty by assessment of questionnaires and three different frailty tools

Other: Frailty and Quality of Life evaluation

Interventions

Frailty and Quality of Life evaluation OTHER

Frailty and Quality of Life evaluation after surgery

Frailty

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with epithelial ovarian cancer scheduled for cytoreductive surgery with curative intent
• Age ≥18 years
• Signed written informed consent

You may not qualify if:

• Not able to understand the Swedish or English language
• Other diagnosis than ovarian cancer on final pathology

Sponsors & Collaborators

• Sahar Salehi: lead

Study Sites (4)

Karolinska University Hospital

Stockholm, Solna, 171 76, Sweden

RECRUITING

Sahlgrenska University Hospital and Sahlgrenska Academy

Gothenburg, 41685, Sweden

NOT YET RECRUITING

Linköping University Hospital

Linköping, 581 85, Sweden

RECRUITING

Skåne University Hospital

Lund, 22185, Sweden

NOT YET RECRUITING

Related Publications (1)

• Hunde D, Ekerstad N, Asp M, Kannisto P, Wedin M, Palmqvist C, Dahm-Kahler P, Brandberg Y, Abraham-Nordling M, Ahlund K, Morlin V, Groes-Kofoed N, Salehi S. Determining the effect of frailty on survival in advanced ovarian cancer: study protocol for a prospective multicentre national cohort study (FOLERO). Acta Oncol. 2025 Feb 5;64:208-213. doi: 10.2340/1651-226X.2025.42292.

  PMID: 39907536 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Sahar Salehi, MD, PhD

  Karolinska University Hospital

  STUDY DIRECTOR

Central Study Contacts

Fihima M Yusuf, MSc

CONTACT

+46725815883; fihima.mohamed-yusuf@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Associate Professor

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 7, 2024
• Study Start: March 11, 2024
• Primary Completion (Estimated): March 28, 2029
• Study Completion (Estimated): March 28, 2029
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

SE (4)