Exercise Response After Revalidation in Cancer Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Oncology, Cardiac Toxicity

Intervention / Treatment
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* Diagnostic Test: Cardiorespiratory exercise test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with cancer Undergoing chemotherapy and/or radiotherapy/hormone therapy Age older than 18 years old - maximum age of 90 years old Willing to enter revalidation in Universitair Ziekenhuis Brussel Signed consent form Exclusion Criteria: Severe aortic stenosis defined as aortic valve aria under 0.6 cm2/m2 Supraventricular arrhythmias Poor image quality for 2D and 3D echocardiography defined as the impossibility to examine of more than 2 adjacent segments 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 Lung cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oncology patients<br>Patients diagnosed with cancer and treated with chemotherapy and/or radiotherapy | Diagnostic Test: Cardiorespiratory exercise test<br>* Cardiorespiratory exercise test to evaluate the exercise tolerance Cardiac imaging for the assessment of the left atrium anatomy and function.<br>* Other names: echocardiography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak volume oxygen - VO2 (L/min) | 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 | 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) | 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) | 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 | 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) | nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Chemotherapy, Cardiorespiratory exercise test, Echocardiography, Revalidation, Cardiovascular magnetic resonance imaging, Oncology