SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS

NCT ID: NCT04862325

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Advanced Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Multimodal prehabilitation

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

Group Type: EXPERIMENTAL

Multimodal Prehabilitation

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Berta Diaz-Feijoo

Study Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berta Diaz-Feijoo, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

M Jose Arguis, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital Clinic Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Biomedical Research Institute la Fe

Valencia, , Spain

Site Status: ACTIVE_NOT_RECRUITING

Countries

Spain

Central Contacts

Berta Diaz-Feijoo, MD PHD

Role: CONTACT

bdiazfe@clinic.cat

932275400 ext. 5534

M Jose Arguis, MD PHD

Role: CONTACT

mjarguis@clinic.cat

932275400 ext. 5534

Facility Contacts

Berta Diaz-Feijoo, MD PHD

Role: primary

bdiazfe@clinic.cat

932275400 ext. 5534

References

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.

Reference Type: BACKGROUND

PMID: 28489682 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35793862 (View on PubMed)

Other Identifiers

HCB/2020/0317

Identifier Type: -

Identifier Source: org_study_id