Extended Versus Short Prehabilitation Programme for Patients With Advanced Ovarian Cancer Undergoing Major Surgery (SOPHIE II)

March 29, 2026 updated by: Berta Diaz-Feijoo, Hospital Clinic of Barcelona

Efficacy of an Extended Prehabilitation Program Versus Standard in Patients With Advanced Ovarian Cancer Within ERAS Protocols

Standard treatment for advanced ovarian cancer includes a combination of cytotoxic chemotherapy and citorreductive surgery. During neo-adjuvant administration of chemotherapy, many patients experience a decline in their functional capacity, leading to an increased risk of postoperative complication as a combination of potential malnutrition, decreased physical activity levels and increased anxiety. Prehabilitation programs conducted within Enhanced Rescovery After Surgery (ERAS) pathways have shown to reduce postoperative complications and length of hospital stay in a diverse group of cancer surgeries and, according to some preliminary evidence, can also increase tumour response in patients receiving neoadjuvant chemotherapy. The aim of this study is to compare two modalities of prehabilitation (extended versus estandard) on postoperative complications and response to neoadjuvant chemotherapy. A total of 225 patients will be randomized in a 2:1 ratio to extended prehabilitation (initiated at the onset of neoadjuvant therapy) or standard prehabilitation (initiated after the course of neoadjuvant therapy is completed). In both groups the prehabilitation program will be delivered in the same manner, including supervised (virtual or facility-based) exercise training, nutritional optimization and psychological support and will be supported by a digital platform.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

225

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 Contact

Study Contact Backup

  • Name: Raquel Sebio Garcia, PhD
  • Phone Number: 0034 634787194
  • Email: sebio@clinic.cat

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
        • Contact:
        • Sub-Investigator:
          • Enrique Moret, PhD
        • Sub-Investigator:
          • Sergio Martínez, PhD
      • Barcelona, Barcelona, Spain, 08036
        • Hospital Clinic of Barcelona
        • Contact:
        • Principal Investigator:
          • Berta Díaz Feijoo, PhD
        • Principal Investigator:
          • Raquel Sebio Garcia, PhD
        • Sub-Investigator:
          • Núria Carreras Dieguez, PhD
        • Sub-Investigator:
          • Graciela Martínez-Pallí, PhD
    • Madrid
      • Madrid, Madrid, Spain, 28041
        • Hospital Universitario 12 de octubre
        • Contact:
        • Principal Investigator:
          • Álvaro Tejerizo, PhD
        • Sub-Investigator:
          • Blanca Gil Ibañez, PhD
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Hospital Universitario Navarra
        • Contact:
        • Principal Investigator:
          • Juan Carlos Muruzabal, PhD
        • Sub-Investigator:
          • Amelia Marí
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La Fe
        • Contact:
        • Principal Investigator:
          • Santiago Domingo Del Pozo, PhD
        • Sub-Investigator:
          • Óscar Díaz Cambronero, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with advanced ovarian cancer (FIGO III and IV)
  • Clinical indication of neoadjuvant chemotherapy followed by cytoreductive surgery
  • No contraindications for exercise training
  • Give written consent to participate

Exclusion Criteria:

  • Patients diagnosed with advanced ovarian cancer scheduled for cytoredutive surgery followed by chemotherapy (no neoadjuvant)
  • Patients with deteriorated functional state (ECOG ≥2) or those with contraindication to exercise training (severe or unstable cardiorespiratory, metabolic, musculoskeletal or neurological conditions)

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extended (Long)-Prehabilitation
Patients allocated to the extended prehabilitation will constitute the experimental group. These patients will receive multimodal prehabilitation including but not limtied to exercise training, nutritional optimization and psychological support from start of neoadjuvant therapy until surgery
Behavioral: Extended (Long)-Prehabilitation

In this study, multimodal prehabilitation will be delivered throughout the course of neoadjuvant therapy and until surgery in the Extended-Prehabilitation arm, while the control group will only receive the intervention once neoadjuvant therapy is completed and the indication for surgery has been confirmed by the multidisciplinary tumour board.

The intervention will consist of three major pillars: a) supervised (virtual or facility-based) exercise training twice a week; b) individual nutritional counselling and supplementation; c) individual or group-based support based on the needs and preferences of the patients. Additional interventions according to the centre standard of care such as iron optimization and smoking cessation will be provided if needed.

Other Names:
  • Exercise Therapy
  • Nutritional optimization
  • Psychological Support
  • Perioperative care
Active Comparator: Standard (Short)-Prehabilitation
Patients allocated to the standard prehabilitation will act as active comparator. In this group, patients will receive only general recommendations and tips during neoadjuvant therapy followed by standard prehabilitation until surgery.
Behavioral: Standard (Short)-Prehabilitation
Standard (short) prehabilitation will include the same three pillars (exercise training twice weekly, individual nutritional counselling and supplementation and psychological support delivered only at the end of neoadjuvant therapy and until surgery (approximately 3-4 weeks). Additional interventions such as smoking cessation and iron optimization will also be included if deemed neccessary in accordance with hospitals' standard of care
Other Names:
  • Psychological Support
  • Perioperative Care
  • Preoperative Exercise
  • Nutritional Optimization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive Complication Index (CCI)
Time Frame: Post-surgery within 30 days
Aggregate score including all postoperative complications and their severity
Post-surgery within 30 days
CA-125 Elimination Rate Constant K (KELIM)
Time Frame: Before surgery
Changes in tumour antigen CA-125 over time (KELIM) will be recorded as a proxy to assess response to neoadjuvant cytotoxic therapy in both arms
Before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-related toxicities
Time Frame: Post-neoadjuvant therapy within three weeks after last cycle
Number and severity (CTCAE v5) of treatment-related toxicities during neoadjuvant therapy will be retrieved in both groups from medical records.
Post-neoadjuvant therapy within three weeks after last cycle
Response to neoadjuvant therapy
Time Frame: Post-surgery within two weeks
Chemotherapy Response Score (CRS) at pathological analysis will be assessed to globally ascertain the response of neoadjuvant chemotherapy in both groups
Post-surgery within two weeks
Rate of Complete tumour resection surgeries
Time Frame: Intraoperatively at the end of surgery
The number of complete tumour resection surgeries (R0) achieved in each group will be recorded at the time of surgery
Intraoperatively at the end of surgery
Postoperative Functional Recovery
Time Frame: 30 days after surgery
Length of hospital stay, Days Out of Hospital at 30 Days (DAOH30) and time to start adjuvant chemotherapy after surgery will be measured to determine the functional recovery of patient after interval surgery
30 days after surgery
Overall Health-Related Quality of Life
Time Frame: After neoadjuvant therapy within two weeks after last cycle
Overall health-Related Quality of Life measured with a general (EORTC QLQ C30) will be captured at baseline (T0) and after neoadjuvant therapy (T1)
After neoadjuvant therapy within two weeks after last cycle
Disease-specific Health Related Quality of Life
Time Frame: After neoadjuvant therapy within two weeks of the last cycle
Disease-specific health related quality of life will be measured with the EORTC QLQ OV28 at baseline (T0) and after neoadjuvant therapy (T1)
After neoadjuvant therapy within two weeks of the last cycle
Overall survival
Time Frame: 36 months after surgery
Overall survival (OS) will be recorded in both groups up to 36 months after surgery.
36 months after surgery
Disease-free Survival (DFS)
Time Frame: 36 months after surgery
Disease-Free Survival (DFS) will be recorded in both groups up to 36 months after surgery.
36 months after surgery

Collaborators and Investigators

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

Sponsor

Hospital Clinic of Barcelona

Collaborators

Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 29, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB-2025-0370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD might be shared if considered of interest for future research studies and/or individual metaanalyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

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.

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