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Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial (PROPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596800
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
André Lopes, Instituto Brasileiro de Controle do Cancer

Brief Summary:
Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Enhanced Recovery After Surgery Other: Prehabilitation Program + Enhanced Recovery After Surgery Other: Enhanced Recovery After Surgery Phase 3

Detailed Description:

Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to multidisciplinary team and blind to surgeons and anaesthesiologists. The aim is test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.

The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Single-Blind (surgeons and anesthesiologists)
Primary Purpose: Supportive Care
Official Title: Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecologic Oncology: a Randomized Clinical Trial
Actual Study Start Date : November 5, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Arm Intervention/treatment
Experimental: Prehabilitation + Enhanced Recovery After Surgery
Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.
Other: Prehabilitation Program + Enhanced Recovery After Surgery
Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
Other Name: Prehabilitation + ERAS

Active Comparator: Enhanced Recovery After Surgery
Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®.
Other: Enhanced Recovery After Surgery
ERAS
Other Name: ERAS protocol




Primary Outcome Measures :
  1. Postoperative recovery time [ Time Frame: Up to 30 postoperative days ]
    Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs


Secondary Outcome Measures :
  1. Complications and Adverse Effects [ Time Frame: Up to 30 postoperative days ]
    Complications and Adverse Effects according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 2017

  2. Readmissions [ Time Frame: Up to 30 postoperative days ]
    Readmission to the Hospital Facilities

  3. Intensive Care Unit admission rates [ Time Frame: Up to 30 postoperative days ]
    Postoperative Intensive Care Unit admission and stay

  4. Health-related Quality of Life [ Time Frame: At Baseline, the week before surgery, then at postoperative days 7, 30 and 60 ]
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

  5. Compliance to the ERAS® program guideline [ Time Frame: Up to 30 postoperative days ]
    Compliance to ERAS® protocol and implementation of the program

  6. Changes in anxiety and depression from baseline [ Time Frame: At Baseline, the week before surgery, then at postoperative days 7, 30 and 60 ]
    Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.

  7. Changes in functional capacity from baseline [ Time Frame: At Baseline, the week before surgery, then at postoperative days 30 and 60 ]
    Patients will perform a 6-Minute Walk Test

  8. Change in muscle strength [ Time Frame: At Baseline, the week before surgery, then at postoperative days 30 and 60 ]
    Muscle strength is measured by using an dynamometer

  9. Change in body mass [ Time Frame: At Baseline, the week before surgery, then at postoperative days 30 and 60 ]
    Body mass is measured by using a bioelectrical impedance analysis

  10. Hospital stay [ Time Frame: Up to 30 days ]
    Days from surgical procedure to hospital discharge

  11. Use of opioids in acute postoperative pain [ Time Frame: Up to 30 days ]
    Use and dosage of opioids in the postoperative period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who sign the Informed Consent Form, indicating that they understand the study procedures and their purpose;
  • Women aged between 18 and 80 years old;
  • Gynecological surgery performed by laparotomy;
  • Patients with Eastern Cooperative Oncology Group Performance Status of at least 2 (ECOG ≤2);
  • Preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks

Exclusion Criteria:

  • Patients under 18 or older than 80 years old;
  • ECOG ≥3;
  • Significant comorbidities, such as: neurological or musculoskeletal disorder, heart disease and / or respiratory failure that prohibit physical exercise;
  • Limitation of ambulation preventing the patient to perform physical exercises;
  • Cognitive deterioration or patients with psychiatric disorder that prevents adherence to the program;
  • Emergency or urgency surgeries;
  • Surgeries by minimally invasive approach (laparoscopy or robotics);
  • Vulvectomy or soft tissue surgery without abdominal approach;
  • Minor gynaecological surgeries such as conizations;
  • Surgeries performed together with other specialties, in which the gynecology team is not primarily responsible for postoperative care;
  • If surgery is performed 21 days after the last day of the prehabilitation program, for any reason

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): NCT04596800


Contacts
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Contact: Andre Lopes, MD +551134744242 andrelopes.cirurgia@gmail.com
Contact: Alayne Yamada, PhD +551134744242 alayne.pesquisa@ibcc-mooca.org.br

Locations
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Brazil
Instituto Brasileiro de Controle do Cancer - IBCC Recruiting
Sao Paulo, Brazil
Contact: Alayne Yamada, PhD    +551134744242    alayne.pesquisa@ibcc-mooca.org.br   
Principal Investigator: Andre Lopes, MD         
Sponsors and Collaborators
Instituto Brasileiro de Controle do Cancer
Investigators
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Principal Investigator: Andre Lopes, MD Instituto Brasileiro de Controle do Cancer
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: André Lopes, MD, Instituto Brasileiro de Controle do Cancer
ClinicalTrials.gov Identifier: NCT04596800    
Other Study ID Numbers: 36924620.7.0000.0072
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication of the results
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After study enrollment
Access Criteria: Public

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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 André Lopes, Instituto Brasileiro de Controle do Cancer:
Prehabilitation
Gynecologic Cancer
ERAS - Enhanced Recovery After Surgery
Gynecologic Surgery