Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04862325

SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Advanced Ovarian Cancer Behavior Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic Barcelona, Barcelona, Spain

Loading trial locations.

About this study

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:

  • High-intensity endurance exercise training program and physical activity promotion remotely controlled with ICT (information and communications technologies).
  • Nutritional counselling to achieve protein intake of 1.5-1.8 g/kg and whey protein supplements.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal Prehabilitation

Other
  • High-intensity endurance exercise training program and physical activity promotion remotely controlled with ICT (information and communications technologies).
  • Nutritional counselling to achieve protein intake of 1.5-1.8 g/kg and whey protein supplements.
  • Psychological intervention including motivational interview, mindfulness meditation and cognitive behavioral therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. Hospital and ICU (intensive care unit) length of stay

    Time frame: postoperative 30 days

  2. 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.

  3. Interval of days between surgery and the start of chemotherapy

    Time frame: From date of surgery up to 6 months

  4. 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.

  5. Cost-effectiveness

    Time frame: Baseline up to 30 days after surgery

    Cost of treatment in the hospital in Euros including prehabilitation and postoperative recovery.

  6. Health Related Quality of Life assesed by EORTC QLC-C30

    Time frame: Baseline and 1 month postoperative

  7. 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)

  8. Overall and disease-free survival of the study groups

    Time frame: 5 years

  9. Nutritional status

    Time frame: Baseline and 1 month postoperative

    GLIM (includes hand-grip)

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: SOPHIE

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2021
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.