SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    146
  • sponsor
    Hospital Clinic of Barcelona
Updated on 9 May 2021

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.

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.

Details
Condition Advanced Ovarian Cancer
Treatment Multimodal prehabilitation
Clinical Study IdentifierNCT04862325
SponsorHospital Clinic of Barcelona
Last Modified on9 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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