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SOPHIE Trial: Surgery in Ovarian Cancer With PreHabilitation In ERAS (SOPHIE)

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ClinicalTrials.gov Identifier: NCT04862325
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Berta Diaz-Feijoo, Hospital Clinic of Barcelona

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Ovarian Cancer Other: Multimodal Prehabilitation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: SOPHIE: Surgery in Ovarian Cancer With PreHabilitation In ERAS: Prospective Multicentre Study
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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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.
Experimental: Multimodal prehabilitation
Patients following the standard preoperative policies of our institution and the multimodal prehabilitation program
 Other: 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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of postoperative complications [ Time Frame: 30 days ]

    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.



Secondary Outcome Measures :
  1. Hospital and ICU (intensive care unit) length of stay [ Time Frame: postoperative 30 days ]
  2. Compliance to the ERAS program. [ Time Frame: postoperative 30 days ]
    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.

  3. Interval of days between surgery and the start of chemotherapy [ Time Frame: From date of surgery up to 6 months ]
  4. Preoperative and postoperative aerobic capacity [ Time Frame: baseline, 1 and 3 month post intervention ]
    Maximum production of carbon dioxide in ml/min during high intensity cardiopulmonar exercise.

  5. Cost-effectiveness [ Time Frame: Baseline up to 30 days after surgery ]
    Cost of treatment in the hospital in Euros including prehabilitation and postoperative recovery.

  6. Health Related Quality of Life assesed by EORTC QLC-C30 [ Time Frame: Baseline and 1 month postoperative ]
  7. Incidence of cognitive deficit [ Time Frame: Baseline and 1 month postoperative ]
    Cognitive assessment based on validated neuropsychological test: T @ M (; Digits WAIS III (Wechsler Adult Intelligence Scale-Third Edition)

  8. Overall and disease-free survival of the study groups [ Time Frame: 5 years ]
  9. Nutritional status [ Time Frame: Baseline and 1 month postoperative ]
    GLIM (includes hand-grip)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862325


Contacts
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Contact: Berta Diaz-Feijoo, MD PHD 932275400 ext 5534 bdiazfe@clinic.cat
Contact: M Jose Arguis, MD PHD 932275400 ext 5534 mjarguis@clinic.cat

Locations
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Spain
Hospital Clinic Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Berta Diaz-Feijoo, MD PHD    932275400 ext 5534    bdiazfe@clinic.cat   
Biomedical Research Institute la Fe Active, not recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Berta Diaz-Feijoo, MD PHD Hospital Clinic of Barcelona
Principal Investigator: M Jose Arguis, MD Hospital Clinic of Barcelona
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Berta Diaz-Feijoo, Study Director, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT04862325    
Other Study ID Numbers: HCB/2020/0317
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Berta Diaz-Feijoo, Hospital Clinic of Barcelona:
Prehabilitation
Advanced ovarian cancer
cytoreductive surgery
postoperative complications
 exercise training
nutrition
physical activity
mindfulness meditation
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type