Back to resultsExercise Response After Revalidation in Cancer Patients
Primary Purpose
Oncology, Cardiac Toxicity
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cardiorespiratory exercise test
Sponsored by
About this trial
This is an interventional diagnostic trial for Oncology focused on measuring Echocardiography, Revalidation, Cardiovascular magnetic resonance imaging, Oncology, Radiotherapy, Chemotherapy, Cardiorespiratory exercise test
Eligibility Criteria
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
Sites / Locations
- Universitair Ziekenhuis Brussel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oncology patients
Arm Description
Patients diagnosed with cancer and treated with chemotherapy and/or radiotherapy
Outcomes
Primary Outcome Measures
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 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 in the respiratory exchange ratio (RER)
represents the ratio between exhaled CO2 and inhale O2 may quantify the grade of the effort
Secondary Outcome Measures
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 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')
Major adverse cardiovascular events (MACE)
nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Full Information
NCT ID
NCT04461392
First Posted
March 20, 2020
Last Updated
July 2, 2020
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT04461392
Brief Title
Exercise Response After Revalidation in Cancer Patients
Official Title
Role of Myocardial Work in the Prediction of Cardiac Dysfunction and Response After Revalidation in Patients With Cancer Undergoing Chemotherapy and/or Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology, Cardiac Toxicity
Keywords
Echocardiography, Revalidation, Cardiovascular magnetic resonance imaging, Oncology, Radiotherapy, Chemotherapy, Cardiorespiratory exercise test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
191 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oncology patients
Arm Type
Experimental
Arm Description
Patients diagnosed with cancer and treated with chemotherapy and/or radiotherapy
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiorespiratory exercise test
Other Intervention Name(s)
cardiac computed tomography, cardiac magnetic resonance, echocardiography
Intervention Description
Cardiorespiratory exercise test to evaluate the exercise tolerance
Cardiac imaging for the assessment of the left atrium anatomy and function.
Primary Outcome Measure Information:
Title
Change in peak volume oxygen - VO2 (L/min)
Description
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
Time Frame
change from baseline (before rehabilitation) at 15 months (after rehabilitation)
Title
Change in the minute ventilation/carbon dioxide production (VE/VCO2) slope
Description
this parameter shows the increase in ventilation in response to CO2 production, thus it measures the ventilatory efficiency
Time Frame
change from baseline (before rehabilitation) at 15 months (after rehabilitation)
Title
Change in the respiratory exchange ratio (RER)
Description
represents the ratio between exhaled CO2 and inhale O2 may quantify the grade of the effort
Time Frame
change from baseline (before rehabilitation) at 15 months (after rehabilitation)
Secondary Outcome Measure Information:
Title
Change in myocardial work (MW)
Description
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)
Time Frame
change from baseline (before rehabilitation) at 15 months (after rehabilitation)
Title
Change in health status
Description
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')
Time Frame
change from baseline (before rehabilitation) at 15 months (after rehabilitation)
Title
Major adverse cardiovascular events (MACE)
Description
nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Droogmans, Professor
Phone
024776009
Email
steven.droogmans@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Cosyns, Professor
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Droogmans, PhD
Phone
024776009
Email
steven.droogmans@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Luiza Luchian
Phone
024776009
Email
marialuiza.luchian@uzbrussel.be
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Exercise Response After Revalidation in Cancer Patients
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