SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS (SOPHIE)

August 4, 2026 updated by: Berta Diaz-Feijoo, Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08036
        • Hospital Clinic Barcelona
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Biomedical Research Institute la Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
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.
Experimental: Multimodal prehabilitation
Patients following the standard preoperative policies of our institution and the multimodal prehabilitation program
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative complications
Time Frame: 30 days

Any deviation from the normal postoperative course and according its severity to the Clavien-Dindo classification, will be considered a complication.

A comprehensive complication index (CCI) scale will be used which assigns a value to each Clavein-Dindo level so a weighted average of the severity of complications can be calculated not only in a qualitatively way, but also numerically.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital and ICU (intensive care unit) length of stay
Time Frame: postoperative 30 days
postoperative 30 days
Compliance to the ERAS program.
Time Frame: postoperative 30 days
Percentage of items of ERAS program that were completed. Key aspects of this protocol include prevention of prolonged fasting allowing oral intake of clear fluids up to 2 hours before induction of anaesthesia, carbohydrate loading, avoidance of mechanical bowel preparation except if a bowel resection is scheduled, thromboprophylaxis; pre-, intra-, and post-operative euvolemia via goal directed fluid therapy, maintenance of normothermia, intraoperative and postoperative opioid-sparing multi-modal analgesia, avoidance the use of surgical drains, early removal of the urine catheter, and an emphasis on early ambulation and feeding.
postoperative 30 days
Interval of days between surgery and the start of chemotherapy
Time Frame: From date of surgery up to 6 months
From date of surgery up to 6 months
Preoperative and postoperative aerobic capacity
Time Frame: baseline, 1 and 3 month post intervention
Maximum production of carbon dioxide in ml/min during high intensity cardiopulmonar exercise.
baseline, 1 and 3 month post intervention
Cost-effectiveness
Time Frame: Baseline up to 30 days after surgery
Cost of treatment in the hospital in Euros including prehabilitation and postoperative recovery.
Baseline up to 30 days after surgery
Health Related Quality of Life assesed by EORTC QLC-C30
Time Frame: Baseline and 1 month postoperative
Baseline and 1 month postoperative
Incidence of cognitive deficit
Time Frame: Baseline and 1 month postoperative
Cognitive assessment based on validated neuropsychological test: T @ M (; Digits WAIS III (Wechsler Adult Intelligence Scale-Third Edition)
Baseline and 1 month postoperative
Overall and disease-free survival of the study groups
Time Frame: 5 years
5 years
Nutritional status
Time Frame: Baseline and 1 month postoperative
GLIM (includes hand-grip)
Baseline and 1 month postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Berta Diaz-Feijoo, MD PHD, Hospital Clinic of Barcelona
  • Principal Investigator: M Jose Arguis, MD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Actual)

April 28, 2026

Study Completion (Actual)

April 28, 2026

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 24, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2020/0317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe