SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS

NCT04862325 | Active Not Recruiting

• 1 other identifier: HCB/2020/0317
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Ovarian Cancer

Keywords

Prehabilitation; Advanced ovarian cancer; cytoreductive surgery; postoperative complications; exercise training; nutrition; physical activity; mindfulness meditation

Outcome Measures

Primary Outcomes (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.

  30 days

Secondary Outcomes (9)

• Hospital and ICU (intensive care unit) length of stay

  postoperative 30 days

• Compliance to the ERAS program.

  postoperative 30 days

• Interval of days between surgery and the start of chemotherapy

  From date of surgery up to 6 months

• Preoperative and postoperative aerobic capacity

  baseline, 1 and 3 month post intervention

• Cost-effectiveness

  Baseline up to 30 days after surgery

Study Arms (2)

Usual care

NO INTERVENTION

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.

Multimodal prehabilitation

EXPERIMENTAL

Patients following the standard preoperative policies of our institution and the multimodal prehabilitation program

Other: Multimodal Prehabilitation

Interventions

Multimodal Prehabilitation OTHER

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

Multimodal prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (2)

Hospital Clinic Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Biomedical Research Institute la Fe

Valencia, Valencia, 46026, Spain

Location

Related Publications (2)

• 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.

  PMID: 28489682 BACKGROUND

• 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.

  PMID: 35793862 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Berta Diaz-Feijoo, MD PHD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• M Jose Arguis, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 28, 2021
• Study Start: January 1, 2021
• Primary Completion: February 20, 2026
• Study Completion: March 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)