SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS

Advanced Ovarian Cancer Clinical Trial

— SOPHIE  

Official title:

SOPHIE: Surgery in Ovarian Cancer With PreHabilitation In ERAS: Prospective Multicentre Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04862325
• Other study ID #: HCB/2020/0317
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Hospital Clinic of Barcelona
• Contact: Berta Diaz-Feijoo, MD PHD
• Phone: 932275400
• Email: bdiazfe[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Ovarian Cancer
• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms

Intervention

Other:
• Multimodal Prehabilitation
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 intervention including motivational interview, mindfulness meditation and cognitive behavioral therapy

Locations

Country	Name	City	State
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Biomedical Research Institute la Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hospital and ICU (intensive care unit) length of stay		postoperative 30 days
Secondary	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.	postoperative 30 days
Secondary	Interval of days between surgery and the start of chemotherapy		From date of surgery up to 6 months
Secondary	Preoperative and postoperative aerobic capacity	Maximum production of carbon dioxide in ml/min during high intensity cardiopulmonar exercise.	baseline, 1 and 3 month post intervention
Secondary	Cost-effectiveness	Cost of treatment in the hospital in Euros including prehabilitation and postoperative recovery.	Baseline up to 30 days after surgery
Secondary	Health Related Quality of Life assesed by EORTC QLC-C30		Baseline and 1 month postoperative
Secondary	Incidence of cognitive deficit	Cognitive assessment based on validated neuropsychological test: T @ M (; Digits WAIS III (Wechsler Adult Intelligence Scale-Third Edition)	Baseline and 1 month postoperative
Secondary	Overall and disease-free survival of the study groups		5 years
Secondary	Nutritional status	GLIM (includes hand-grip)	Baseline and 1 month postoperative