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Study identifier: NCT04862325 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: CompletedSOPHIE

SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS

Condition: Advanced Ovarian Cancer  ·  Sponsor: Hospital Clinic of Barcelona

PhaseNA
Planned participants158
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where2 locations

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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 complication rates that may result in a strong negative impact on the clinical results due to the delay with the start of adjuvant chemotherapy as well as the costs from the surgical process. Multimodal prehabilitation has emerged as an innovative intervention that focuses on optimizing physiological and psychological resilience to withstand the upcoming stress of surgery. It has been shown to reduce postoperative complications in major abdominal surgery, but has not been assessed yet in abdominal onco-gynecological surgery.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: 1. 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 . 2. Patients with Eastern Cooperative Oncology Group (ECOG) performance status 2-0. 3. Adherence of at least 75 % of the program or minimum of 6 sessions. Exclusion Criteria: 1. Surgery without a minimum of 3 weeks of prehabilitation time. 2. Unstable respiratory or heart disease. 3. Locomotor or cognitive limitations that makes not feasible the adherence to the program. 4. Refusal of the patient.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (2)

Hospital Clinic BarcelonaBarcelona, Barcelona, Spain
Biomedical Research Institute la FeValencia, Valencia, Spain

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BarcelonaValencia

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