- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04862325
SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS (SOPHIE)
SOPHIE: Surgery in Ovarian Cancer With PreHabilitation In ERAS: Prospective Multicentre Study
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic Barcelona
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Valencia, Spain, 46026
- Active, not recruiting
- Biomedical Research Institute la Fe
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
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Experimental: Multimodal prehabilitation
Patients following the standard preoperative policies of our institution and the multimodal prehabilitation program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of postoperative complications
Time Frame: 30 days
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital and ICU (intensive care unit) length of stay
Time Frame: postoperative 30 days
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postoperative 30 days
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Compliance to the ERAS program.
Time Frame: postoperative 30 days
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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.
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postoperative 30 days
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Interval of days between surgery and the start of chemotherapy
Time Frame: From date of surgery up to 6 months
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From date of surgery up to 6 months
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Preoperative and postoperative aerobic capacity
Time Frame: baseline, 1 and 3 month post intervention
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Maximum production of carbon dioxide in ml/min during high intensity cardiopulmonar exercise.
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baseline, 1 and 3 month post intervention
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Cost-effectiveness
Time Frame: Baseline up to 30 days after surgery
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Cost of treatment in the hospital in Euros including prehabilitation and postoperative recovery.
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Baseline up to 30 days after surgery
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Health Related Quality of Life assesed by EORTC QLC-C30
Time Frame: Baseline and 1 month postoperative
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Baseline and 1 month postoperative
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Incidence of cognitive deficit
Time Frame: Baseline and 1 month postoperative
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Cognitive assessment based on validated neuropsychological test: T @ M (; Digits WAIS III (Wechsler Adult Intelligence Scale-Third Edition)
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Baseline and 1 month postoperative
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Overall and disease-free survival of the study groups
Time Frame: 5 years
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5 years
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Nutritional status
Time Frame: Baseline and 1 month postoperative
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GLIM (includes hand-grip)
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Baseline and 1 month postoperative
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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 Jul 6:ijgc-2022-003652. doi: 10.1136/ijgc-2022-003652. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- HCB/2020/0317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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