NCT04862325

SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS

SOPHIE: Surgery in Ovarian Cancer With PreHabilitation In ERAS: Prospective Multicentre Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 (primary cytoreductive surgery, interval surgery and secondary cytoreductive surgery in advanced ovarian cancer). Design: Multicenter randomized controlled clinical trial. Subjects: 146 patients: 73 in the intervention group and 73 in the control group. Intervention group: PreHAB intervention consists on: 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 coping. Control group will receive standard preoperative care. Both groups will receive perioperative care in accordance with the enhanced recovery after surgery (ERAS) guidelines. Measures: Aerobic capacity (incremental stress test), physical activity, operative complications and hospital length and associated costs.

Conditions

• Advanced Ovarian Cancer

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2021-01-01
• Primary completion: 2026-02-20
• Completion: 2026-03-31
• First posted: 2021-04-28
• Last updated: 2026-02-17

Locations

2 sites across 1 country: Spain