Clinical trial NCT04862325: SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS
Official title: SOPHIE: Surgery in Ovarian Cancer With PreHabilitation In ERAS: Prospective Multicentre Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Ovarian Cancer
Keywords: Prehabilitation
Advanced ovarian cancer
cytoreductive surgery
postoperative complications
exercise training
nutrition
physical activity
mindfulness meditation
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: Hospital and ICU (intensive care unit) length of stay
timeFrame: postoperative 30 days
measure: Compliance to the ERAS program.
timeFrame: postoperative 30 days
measure: Interval of days between surgery and the start of chemotherapy
timeFrame: From date of surgery up to 6 months
measure: Preoperative and postoperative aerobic capacity
timeFrame: baseline, 1 and 3 month post intervention
measure: Cost-effectiveness
timeFrame: Baseline up to 30 days after surgery
measure: Health Related Quality of Life assesed by EORTC QLC-C30
timeFrame: Baseline and 1 month postoperative
measure: Incidence of cognitive deficit
timeFrame: Baseline and 1 month postoperative
measure: Overall and disease-free survival of the study groups
timeFrame: 5 years
measure: Nutritional status
timeFrame: Baseline and 1 month postoperative
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Valencia
country: Spain
facility: Biomedical Research Institute la Fe
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Berta Diaz-Feijoo, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: M Jose Arguis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
citation: Diaz-Feijoo B, Agusti N, Sebio R, Siso M, Carreras-Dieguez N, Domingo S, Diaz-Cambronero O, Torne A, Martinez-Palli G, Arguis MJ. A multimodal prehabilitation program for the reduction of post-operative complications after surgery in advanced ovarian cancer under an ERAS pathway: a randomized multicenter trial (SOPHIE). Int J Gynecol Cancer. 2022 Nov 7;32(11):1463-1468. doi: 10.1136/ijgc-2022-003652.