Status:
UNKNOWN
SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
Advanced Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The treatment of choice in advanced ovarian cancer is a cytoreductive surgery combined with chemotherapeutic treatment. This complex and aggressive surgery is associated with high postoperative compli...
Detailed Description
Main objective: To determine the efficacy of multimodal prehabilitation in decreasing postoperative complications in patients undergoing gynecological cancer surgery of high complexity by laparotomy (...
Eligibility Criteria
Inclusion
- Patients with advanced ovarian cancer subject to primary debulking surgery or interval surgery after 3-4 cycles of chemotherapy or secondary and / or tertiary debulking surgery .
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 2-0.
- Adherence of at least 75 % of the program or minimum of 6 sessions.
Exclusion
- Surgery without a minimum of 3 weeks of prehabilitation time.
- Unstable respiratory or heart disease.
- Locomotor or cognitive limitations that makes not feasible the adherence to the program.
- Refusal of the patient.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04862325
Start Date
January 1 2021
End Date
December 31 2024
Last Update
March 7 2023
Active Locations (2)
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1
Hospital Clinic Barcelona
Barcelona, Spain, 08036
2
Biomedical Research Institute la Fe
Valencia, Spain, 46026