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OncologyNCT04461392

Exercise Response After Revalidation in Cancer Patients

A study testing Cardiorespiratory exercise test in people with Oncology and Cardiac Toxicity, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Oncology, Cardiac Toxicity
What is being tested?
Cardiorespiratory exercise test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
191 participants
Where
1 siteBelgium
Study dates
Aug 2020to Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Steven Droogmans, Professor contact

024776009

steven.droogmans@uzbrussel.be

Belgium1 site

  • Universitair Ziekenhuis Brussel

    Jette, 1090

    Steven Droogmans, PhD, 024776009, steven.droogmans@uzbrussel.be

    Luiza Luchian, 024776009, marialuiza.luchian@uzbrussel.be

Other trials in Belgium

About this study

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

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).

Read the 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.

Being tested
Cardiorespiratory exercise test
Keywords
Echocardiography, Revalidation, Cardiovascular magnetic resonance imaging, Oncology, Radiotherapy, Chemotherapy, Cardiorespiratory exercise test
Medical subject headings
Neoplasms, Cardiotoxicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiorespiratory exercise testDiagnostic test

    Also called cardiac computed tomography, cardiac magnetic resonance, echocardiography

    • Cardiorespiratory exercise test to evaluate the exercise tolerance
    • Cardiac imaging for the assessment of the left atrium anatomy and function.
Study groups in NCT04461392
Study groupRoleWhat they receive
Oncology patientsExperimentalPatients diagnosed with cancer and treated with chemotherapy and/or radiotherapy
Receives: Diagnostic Test: Cardiorespiratory exercise test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

  3. Change in the respiratory exchange ratio (RER)

    represents the ratio between exhaled CO2 and inhale O2 may quantify the grade of the effort

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

Secondary outcomes (3)

  1. 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)

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

  2. 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')

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

  3. Major adverse cardiovascular events (MACE)

    nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2020
  2. Study startAug 2020 (estimated)
  3. Primary completionJul 2021 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
191 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04461392
Sponsor's protocol ID
BC032020_1
Status last verified
Jul 2020
First submitted
20 Mar 2020
Last updated
8 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27567406

  • 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.

    PubMed 30092965

  • 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.

    PubMed 31826679

  • 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.

    PubMed 30603649

  • 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.

    PubMed 31515694

  • 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.

    PubMed 30488501

  • 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.

    PubMed 27206819

  • 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.

    PubMed 28681553

Questions about this trial

What is this clinical trial studying?

A study testing Cardiorespiratory exercise test in people with Oncology and Cardiac Toxicity, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Steven Droogmans, Professor (024776009, steven.droogmans@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in peak volume oxygen - VO2 (L/min) (time frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04461392, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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