Exercise Response After Revalidation in Cancer Patients

Not Applicable

• Conditions: Cardiac Toxicity; Oncology
• Interventions: Diagnostic Test: Cardiorespiratory exercise test

• Registration Number: NCT04461392
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study First Submitted: 2020-03-20
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-02
• Last Update Submitted: 2020-07-02
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08
• Study Start: 2020-08
• Primary Completion: 2021-07
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 191

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oncology patients	Cardiorespiratory exercise test	Patients diagnosed with cancer and treated with chemotherapy and/or radiotherapy

Primary Outcome Measures

Name	Time	Method
Change in the minute ventilation/carbon dioxide production (VE/VCO2) slope	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 in peak volume oxygen - VO2 (L/min)	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 in the respiratory exchange ratio (RER)	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

Secondary Outcome Measures

Name	Time	Method
Change in myocardial work (MW)	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 in health status	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')
Major adverse cardiovascular events (MACE)	through study completion, an average of 1 year	nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Belgium