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

October 27, 2023 updated by: André Lopes, Instituto Brasileiro de Controle do Cancer

Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecologic Oncology: a Randomized Clinical Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

194

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Recruiting
        • Instituto Brasileiro De Controle Do Câncer - IBCC
        • Contact:
        • Principal Investigator:
          • Andre Lopes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • ERAS protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 30 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmissions
Time Frame: Up to 30 postoperative days
Readmission to the Hospital Facilities
Up to 30 postoperative days
Intensive Care Unit admission rates
Time Frame: Up to 30 postoperative days
Postoperative Intensive Care Unit admission and stay
Up to 30 postoperative days
Hospital stay
Time Frame: Up to 30 days
Days from surgical procedure to hospital discharge
Up to 30 days
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
Up to 30 postoperative days
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)
At Baseline, the week before surgery, then at postoperative days 7, 30 and 60
Compliance to the ERAS® program guideline
Time Frame: Up to 30 postoperative days
Compliance to ERAS® protocol and implementation of the program
Up to 30 postoperative days
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.
At Baseline, the week before surgery, then at postoperative days 7, 30 and 60
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
At Baseline, the week before surgery, then at postoperative days 30 and 60
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
At Baseline, the week before surgery, then at postoperative days 30 and 60
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
At Baseline, the week before surgery, then at postoperative days 30 and 60
Use of opioids in acute postoperative pain
Time Frame: Up to 30 days
Use and dosage of opioids in the postoperative period
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Brasileiro de Controle do Cancer

Investigators

  • Principal Investigator: Andre Lopes, MD, Instituto Brasileiro de Controle Do Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2020

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 18, 2020

First Submitted That Met QC Criteria

October 18, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 36924620.7.0000.0072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After publication of the results

IPD Sharing Time Frame

After study enrollment

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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