SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS

Hospital Clinic of Barcelona

Status: Enrolling

Conditions: Advanced Ovarian Cancer

Treatments: Other: Multimodal Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04862325

HCB/2020/0317

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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146 participants in 2 patient groups

Usual care

No Intervention group

Description:

Control group will follow the standard preoperative measures "Enhanced Recovery After Surgery" (ERAS®) established in the protocols of our hospital. Standard preoperative measures: recommendation of nutritional and physical activity and advice to stop smoking and reduce alcohol intake; optimization of preoperative pathologies including anaemia. An information document on ERAS® measures in our center will be attached to all of them.

Multimodal prehabilitation

Experimental group

Description:

Patients following the standard preoperative policies of our institution and the multimodal prehabilitation program

Treatment:

Other: Multimodal Prehabilitation