Clinical trial NCT03480087: Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma
Official title: Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Non-Hodgkin
Hodgkin Lymphoma
Toxicity, Cardiac
Keywords: strain-rate echocardiography
chemotherapy
radiotherapy, mediastinal
Lymphoma
Hodgkin
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 118
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient 19-70 years old with HD or PMBCL or DLBCL requiring treatment with chemotherapy or chemotherapy plus mediastinal radiotherapy suitable for a strain-rate echocardiograpy evaluation

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.


Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 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)
measure: Global Longitudinal Strain (GLS)
timeFrame: 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 outcomes:
measure: Anthracycline cumulative dose
timeFrame: 4/6 month after baseline (end of chemotherapy)
measure: T troponin
timeFrame: 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)
Other outcomes:
Locations:
city: Torino
country: Italy
facility: SC Ematologia - AOU Città della salute e della Scienza di Torino
Study officials:
References: