Exercise Response After Revalidation in Cancer Patients

NCT04461392 | Unknown

• 1 other identifier: BC032020_1
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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).

Conditions

Oncology; Cardiac Toxicity

Keywords

Echocardiography; Revalidation; Cardiovascular magnetic resonance imaging; Oncology; Radiotherapy; Chemotherapy; Cardiorespiratory exercise test

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in myocardial work (MW)

  change from baseline (before rehabilitation) at 15 months (after rehabilitation)

• Change in health status

  change from baseline (before rehabilitation) at 15 months (after rehabilitation)

• Major adverse cardiovascular events (MACE)

  through study completion, an average of 1 year

Study Arms (1)

Oncology patients

EXPERIMENTAL

Patients diagnosed with cancer and treated with chemotherapy and/or radiotherapy

Diagnostic Test: Cardiorespiratory exercise test

Interventions

Cardiorespiratory exercise test DIAGNOSTIC_TEST

* Cardiorespiratory exercise test to evaluate the exercise tolerance * Cardiac imaging for the assessment of the left atrium anatomy and function.

Also known as: cardiac computed tomography, cardiac magnetic resonance, echocardiography

Oncology patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Location

Related Publications (8)

• Zamorano JL, Lancellotti P, Rodriguez Munoz 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. No abstract available.

  PMID: 27567406 BACKGROUND

• 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.

  PMID: 30092965 BACKGROUND

• 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.

  PMID: 31826679 BACKGROUND

• 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.

  PMID: 30603649 BACKGROUND

• 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.

  PMID: 31515694 BACKGROUND

• 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.

  PMID: 30488501 BACKGROUND

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-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. No abstract available.

  PMID: 27206819 BACKGROUND

• 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.

  PMID: 28681553 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Cardiotoxicity

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Bernard Cosyns, Professor

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Droogmans, Professor

CONTACT

024776009; steven.droogmans@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: July 8, 2020
• Study Start: August 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2022
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)