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SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS
Sponsor: Hospital Clinic of Barcelona
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 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.
Official title: SOPHIE: Surgery in Ovarian Cancer With PreHabilitation In ERAS: Prospective Multicentre Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
146
Start Date
2021-01-01
Completion Date
2026-03-31
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Multimodal Prehabilitation
1. High-intensity endurance exercise training program and physical activity promotion remotely controlled with ICT (information and communications technologies). 2. Nutritional counselling to achieve protein intake of 1.5-1.8 g/kg and whey protein supplements. 3. Psychological intervention including motivational interview, mindfulness meditation and cognitive behavioral therapy
Locations (2)
Hospital Clinic Barcelona
Barcelona, Barcelona, Spain
Biomedical Research Institute la Fe
Valencia, Valencia, Spain