NCT04862325Completed
SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS
SOPHIE: Surgery in Ovarian Cancer With PreHabilitation In ERAS: Prospective Multicentre Study
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 158 (actual)
- First submitted
- 12 Apr 2021
- Start date
- 20 Apr 2021
- Primary completion date
- 28 Apr 2026
- Lead sponsor
- Hospital Clinic of Barcelona
- Diseases
- Ovarian cancer
- NCT number
- NCT04862325
What you commit to
- Study type: Interventional
- Participants enrolled: 158
- From 20 Apr 2021 to the primary completion date, 28 Apr 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgery without a minimum of 3 weeks of prehabilitation time.
Other illness
- Unstable respiratory or heart disease.
Other
- Locomotor or cognitive limitations that makes not feasible the adherence to the program.
- Refusal of the patient.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Biomedical Research Institute la Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.