AzTrials
AzTrials

Advanced Ovarian CancerSOPHIENCT04862325

SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS

A study testing Multimodal Prehabilitation in people with Advanced Ovarian Cancer, run by Hospital Clinic of Barcelona at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Ovarian Cancer
What is being tested?
Multimodal Prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
2 sitesSpain
Study dates
20 Apr 2021to 28 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Clinic Barcelona

    Barcelona, Barcelona, 08036

  • Biomedical Research Institute la Fe

    Valencia, Valencia, 46026

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Multimodal Prehabilitation
Keywords
Prehabilitation, Advanced ovarian cancer, cytoreductive surgery, postoperative complications, exercise training, nutrition, physical activity, mindfulness meditation
Medical subject headings
Postoperative Complications, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal PrehabilitationOther

    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
Study groups in NCT04862325
Study groupRoleWhat they receive
Usual careNo interventionControl 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 prehabilitationExperimentalPatients following the standard preoperative policies of our institution and the multimodal prehabilitation program
Receives: Other: Multimodal Prehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of postoperative complications

    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.

    Measured: 30 days

Secondary outcomes (9)

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

    Measured: postoperative 30 days

  2. Compliance to the ERAS program.

    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.

    Measured: postoperative 30 days

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

    Measured: From date of surgery up to 6 months

  4. Preoperative and postoperative aerobic capacity

    Maximum production of carbon dioxide in ml/min during high intensity cardiopulmonar exercise.

    Measured: baseline, 1 and 3 month post intervention

  5. Cost-effectiveness

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

    Measured: Baseline up to 30 days after surgery

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

    Measured: Baseline and 1 month postoperative

  7. Incidence of cognitive deficit

    Cognitive assessment based on validated neuropsychological test: T @ M (; Digits WAIS III (Wechsler Adult Intelligence Scale-Third Edition)

    Measured: Baseline and 1 month postoperative

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

    Measured: 5 years

  9. Nutritional status

    GLIM (includes hand-grip)

    Measured: Baseline and 1 month postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2021
  2. Study start20 Apr 2021
  3. Primary completion28 Apr 2026
  4. Study completion28 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04862325
Sponsor's protocol ID
HCB/2020/0317
Acronym
SOPHIE
Status last verified
Aug 2026
First submitted
12 Apr 2021
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28489682

  • 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.

    PubMed 35793862

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal Prehabilitation in people with Advanced Ovarian Cancer, run by Hospital Clinic of Barcelona at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative complications (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04862325, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in