Exercise Response After Revalidation in Cancer Patients

NCT ID: NCT04461392

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Oncology Cardiac Toxicity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Oncology patients

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

Group Type EXPERIMENTAL

Cardiorespiratory exercise test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Cardiorespiratory exercise test

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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cardiac computed tomography cardiac magnetic resonance echocardiography

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Bernard Cosyns

Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernard Cosyns, Professor

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Jette, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Steven Droogmans, Professor

Role: CONTACT

024776009

Facility Contacts

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Steven Droogmans, PhD

Role: primary

024776009

Luiza Luchian

Role: backup

024776009

References

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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.

Reference Type BACKGROUND
PMID: 27567406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30092965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31826679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30603649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31515694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30488501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27206819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28681553 (View on PubMed)

Other Identifiers

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BC032020_1

Identifier Type: -

Identifier Source: org_study_id

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