Exercise Response After Revalidation in Cancer Patients

Oncology Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04461392
• Other study ID #: BC032020_1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: August 2022

Study information

• Verified date: July 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: Steven Droogmans, Professor
• Phone: 024776009
• Email: steven.droogmans[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 191
• Est. completion date: August 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Toxicity
• Cardiotoxicity
• Neoplasms
• Oncology

Intervention

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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (8)

Ferreira de Souza T, Quinaglia A C Silva T, Osorio Costa F, Shah R, Neilan TG, Velloso L, Nadruz W, Brenelli F, Sposito AC, Matos-Souza JR, Cendes F, Coelho OR, Jerosch-Herold M, Coelho-Filho OR. Anthracycline Therapy Is Associated With Cardiomyocyte Atrophy and Preclinical Manifestations of Heart Disease. JACC Cardiovasc Imaging. 2018 Aug;11(8):1045-1055. doi: 10.1016/j.jcmg.2018.05.012. — View Citation

Galli E, Vitel E, Schnell F, Le Rolle V, Hubert A, Lederlin M, Donal E. Myocardial constructive work is impaired in hypertrophic cardiomyopathy and predicts left ventricular fibrosis. Echocardiography. 2019 Jan;36(1):74-82. doi: 10.1111/echo.14210. Epub 2018 Nov 29. — View Citation

Kosmas CE, Silverio D, Sourlas A, Montan PD, Guzman E. Role of spironolactone in the treatment of heart failure with preserved ejection fraction. Ann Transl Med. 2018 Dec;6(23):461. doi: 10.21037/atm.2018.11.16. Review. — View Citation

Moneghetti KJ, Kobayashi Y, Christle JW, Ariyama M, Vrtovec B, Kouznetsova T, Wilson A, Ashley E, Wheeler MT, Myers J, Haddad F. Contractile reserve and cardiopulmonary exercise parameters in patients with dilated cardiomyopathy, the two dimensions of exercise testing. Echocardiography. 2017 Aug;34(8):1179-1186. doi: 10.1111/echo.13623. Epub 2017 Jul 6. — View Citation

Piepoli MF, Abreu A, Albus C, Ambrosetti M, Brotons C, Catapano AL, Corra U, Cosyns B, Deaton C, Graham I, Hoes A, Lochen ML, Matrone B, Redon J, Sattar N, Smulders Y, Tiberi M. Update on cardiovascular prevention in clinical practice: A position paper of the European Association of Preventive Cardiology of the European Society of Cardiology. Eur J Prev Cardiol. 2020 Jan;27(2):181-205. doi: 10.1177/2047487319893035. Epub 2019 Dec 12. — View Citation

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. Erratum in: Eur Heart J. 2016 Dec 30;:. — View Citation

Schrub F, Schnell F, Donal E, Galli E. Myocardial work is a predictor of exercise tolerance in patients with dilated cardiomyopathy and left ventricular dyssynchrony. Int J Cardiovasc Imaging. 2020 Jan;36(1):45-53. doi: 10.1007/s10554-019-01689-4. Epub 2019 Sep 12. — View Citation

Zamorano JL, Lancellotti P, Rodriguez Muñoz D, Aboyans V, Asteggiano R, Galderisi M, Habib G, Lenihan DJ, Lip GYH, Lyon AR, Lopez Fernandez T, Mohty D, Piepoli MF, Tamargo J, Torbicki A, Suter TM; ESC Scientific Document Group. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur Heart J. 2016 Sep 21;37(36):2768-2801. doi: 10.1093/eurheartj/ehw211. Epub 2016 Aug 26. Erratum in: Eur Heart J. 2016 Dec 24;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	Major adverse cardiovascular events (MACE)	nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death	through study completion, an average of 1 year