Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma

Study Overview
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Brief Summary
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Treatments-related cardiotoxicity is a critical issue in long term lymphoma survivors, particularly at young age, and its early identification is important to prevent clinically relevant cardiac events. Complete echocardiographic assessment including 2-dimension global longitudinal strain (2D-GLS), seems to be an effective tools in detecting preclinical systolic changes to the cardiac function even when the ejection fraction is preserved. The aim of Cardiocare study is to investigate early detection of subclinical chemo and radiation-induced changes in left ventricular function using 2D-GLS.

Official Title
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Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma

Conditions
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Lymphoma, Non-Hodgkin, Hodgkin Lymphoma, Toxicity, Cardiac

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Diagnosis of Hodgkin Disease (HD) or Primary Mediastinal B-cell lymphoma (PMBCL) or diffuse large B-cell lymphoma (DLBCL) Disease requiring treatment with anthracycline containing regimen only (cohort A) or anthracycline containing regimen followed by mediastinal radiotherapy (cohort B) Written informed consent Exclusion Criteria: Age > 70 years Unable to perform anthracyline containing regimen Previous treatment with mediastinal radiotherapy Kidney failure (defined as creatinine x2 UNL) or liver failure (defined as AST and ALT x2 UNL) ECOG PS > 2 Echocardiographic acoustic windows not suitable for strain evaluation Any other conditions or situations preventing patients to sign informed consent

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy alone<br>Patient treated with anthracycline containing chemotherapy | |
| Chemotherapy plus radiotherapy<br>Patient treated with anthracycline containing chemotherapy followed by mediastinal radiotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (LVEF) | Left ventricular ejection fraction measured by echocardiography | Baseline, Change of LVEF from Baseline at 4/6 month (end of chemotherapy), Change of LVEF from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of LVEF from Baseline at 9/11 months (3 months after treatment completion) | 
| Global Longitudinal Strain (GLS) | Global Longitudinal Strain measured by strain-rate echocardiography | Baseline, Change of GLS from Baseline at 4/6 month (end of chemotherapy), Change of GLS from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of GLS from Baseline at 9/11 months (3 months after treatment completion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthracycline cumulative dose | Anthracycline cumulative dose | 4/6 month after baseline (end of chemotherapy) | 
| T troponin | T troponin rate | Baseline, Before each chemotherapy administration, 4/6 month after baseline (end of chemotherapy), 6/8 months after baseline (end of radiotherapy - if applicable), 9/11 months after baseline (3 months after treatment completion) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hodgkin, strain-rate echocardiography, chemotherapy, radiotherapy, mediastinal, Lymphoma