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

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)

Overall Status

Completed

CT.gov ID

NCT03480087

Collaborator

(none)

118

Enrollment

Location

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin Hodgkin Lymphoma Toxicity, Cardiac

Study Design

Study Type:

Observational

Actual Enrollment :

118 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jul 1, 2022

Actual Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Chemotherapy alone Patient treated with anthracycline containing chemotherapy
Chemotherapy plus radiotherapy Patient treated with anthracycline containing chemotherapy followed by mediastinal radiotherapy

Outcome Measures

Primary Outcome Measures

Left ventricular ejection fraction (LVEF) [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)]
Left ventricular ejection fraction measured by echocardiography
Global Longitudinal Strain (GLS) [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)]
Global Longitudinal Strain measured by strain-rate echocardiography

Secondary Outcome Measures

Anthracycline cumulative dose [4/6 month after baseline (end of chemotherapy)]
Anthracycline cumulative dose
T troponin [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)]
T troponin rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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