Exercise Response After Revalidation in Cancer Patients

July 2, 2020 updated by: Bernard Cosyns, Universitair Ziekenhuis Brussel

Role of Myocardial Work in the Prediction of Cardiac Dysfunction and Response After Revalidation in Patients With Cancer Undergoing Chemotherapy and/or Radiotherapy

This study regarding oncological patients for rehabilitation after specific cancer therapy involves three aims: (1) to evaluate the predictive value of myocardial work parameters on the improvement of exercise performance after rehabilitation, (2) to determine which echocardiographic parameters are more suitable in predicting cardiac dysfunction, and (3) to evaluate the correlation between echocardiographic parameters and fibrosis detected by cardiac magnetic resonance imaging (CMR).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Myocardial work (MW) provides an estimation of cardiac function by combining global longitudinal strain (GLS) with blood pressure values obtained non-invasively, being less load dependent than standard GLS. The investigator hypothesize that myocardial work could be a useful marker for predicting the exercise performance after chemotherapy and/or radiotherapy in oncological patients undergoing rehabilitation. Moreover, this study may provide additional information in optimal selection for rehabilitation programs.

Study Type

Interventional

Enrollment (Anticipated)

191

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Belgium
      • Jette, Belgium, 1090
        • Universitair Ziekenhuis Brussel

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 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients diagnosed with cancer
  2. Undergoing chemotherapy and/or radiotherapy/hormone therapy
  3. Age older than 18 years old - maximum age of 90 years old
  4. Willing to enter revalidation in Universitair Ziekenhuis Brussel
  5. Signed consent form

Exclusion Criteria:

  1. Severe aortic stenosis defined as aortic valve aria under 0.6 cm2/m2
  2. Supraventricular arrhythmias
  3. Poor image quality for 2D and 3D echocardiography defined as the impossibility to examine of more than 2 adjacent segments
  4. Resistant hypertension defined as uncontrolled blood pressure values under current European guidelines, Systolic Blood Pressure more than 140 mmHg and/or Diastolic Blood Pressure more than 80 mmHg
  5. Lung cancer

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: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oncology patients
Patients diagnosed with cancer and treated with chemotherapy and/or radiotherapy
Diagnostic test: Cardiorespiratory exercise test
  • Cardiorespiratory exercise test to evaluate the exercise tolerance
  • Cardiac imaging for the assessment of the left atrium anatomy and function.
Other Names:
  • echocardiography
  • cardiac computed tomography
  • cardiac magnetic resonance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in peak volume oxygen - VO2 (L/min)
Time Frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
represents the maximum oxygen consumption during incremental exercise that is measured during Cardiopulmonary Exercise test (CPET), being a measure of aerobic capacity of the subject
change from baseline (before rehabilitation) at 15 months (after rehabilitation)
Change in the minute ventilation/carbon dioxide production (VE/VCO2) slope
Time Frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
this parameter shows the increase in ventilation in response to CO2 production, thus it measures the ventilatory efficiency
change from baseline (before rehabilitation) at 15 months (after rehabilitation)
Change in the respiratory exchange ratio (RER)
Time Frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
represents the ratio between exhaled CO2 and inhale O2 may quantify the grade of the effort
change from baseline (before rehabilitation) at 15 months (after rehabilitation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in myocardial work (MW)
Time Frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)

Myocardial work (MW) is a non-invasive, less load-dependent echocardiographic parameter obtained during standard transthoracic echography using the pressure-strain loop data.

This parameter consists of the following measurements: Global constructive work (GCW) Global wasted work (GWW), Global work index (GWI), and Global work efficiency (GWE)
change from baseline (before rehabilitation) at 15 months (after rehabilitation)
Change in health status
Time Frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)

Self-assessment of the generic health status using the EQ-5D-5L questionnaire. This questionnaire assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, on a five-level scale.

In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS) from 0 ('the worst health you can imagine') - 100 ('the best health you can imagine')
change from baseline (before rehabilitation) at 15 months (after rehabilitation)
Major adverse cardiovascular events (MACE)
Time Frame: through study completion, an average of 1 year
nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Bernard Cosyns, Professor, Universitair Ziekenhuis Brussel

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 (ANTICIPATED)

August 1, 2020

Primary Completion (ANTICIPATED)

July 1, 2021

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

July 2, 2020

First Posted (ACTUAL)

July 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 2, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC032020_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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