Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction

Study Overview
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Brief Summary
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The investigators use the cancer registration system of National Cheng Kung University Hospital to timely screen and evaluate those patients having breast cancer or lymphoma to enroll patients to participate in this clinical trial. The investigators planned an earlier initiation of Sacubitril/Valsartan treatment on breast cancer and lymphoma patients before the chemotherapy, and starting therapeutic intervention by Sacubitril/Valsartan once the heart damage sign appeared via novel echocardiography. The investigators aim to assess the protective and therapeutic benefit of cardioprotective drugs on the cardiotoxicity of anti-cancer therapy.

Detailed Description
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The investigators use the cancer registration system of National Cheng Kung University Hospital to timely screen and evaluate those patients having breast cancer or lymphoma to enroll patients to participate in this clinical trial. Also, the Patient Recruitment System support to complete the patients' database. The investigators cooperate with other hospitals in South Taiwan to carry on an early phase clinical trial, named Strategy by novel anti-heart failure therapy on early phase Cancer Therapeutics-Related Cardiac Dysfunction (CTRCD) patients focusing on the either preventive strategy to earlier initiation of Sacubitril/Valsartan treatment on breast cancer and lymphoma patients before the chemotherapy, and starting therapeutic intervention by Sacubitril/Valsartan once the heart damage sign appeared via novel echocardiography, and collect clinical and genetic information from the enrolled patients. These patients randomized into 2 groups: cardioprotective drug vs. placebo. The regular assessment of cardiac function is as following: baseline (prior to anti-cancer treatment) and every 3 months. Thereafter. The investigators aim to assess the protective and/or therapeutic benefit of cardioprotective drugs on the cardiotoxicity of anti-cancer therapy.

Official Title
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Strategy Therapy on Early Phase Cancer Therapeutics-Related Cardiac Dysfunction Patients

Conditions
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Chemotherapeutic Toxicity, Cardiotoxicity, Heart Failure, Breast Cancer, Lymphoma

Intervention / Treatment
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* Drug: Prevention therapy
* Drug: Rescue therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are newly diagnosed with breast cancer or lymphoma and never accepted anti-cancer therapy Age 20-65 years old Systolic blood pressure ≥ 110 mmHg Exclusion Criteria: End-stage renal disease (estimated Glomerulus Filtration Rate <15 mL/min/1.73 m2) Echocardiography Baseline left ventricle ejection fraction < 50% Allergy history to angiotensin receptor blockers Life expectancy < 1 year Pregnancy Unwilling to participate in this clinical study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention therapy<br>Sacubitril/Valsartan (25/80) mg twice a day for 1 year | Drug: Prevention therapy<br>* Sacubitril/Valsartan (25/80) mg twice a day for 1 year<br>|
| No Intervention: Conventional therapy<br>No intervention | |
| No Intervention: Global longitudinal strain (GLS) function decreased >15%, No intervention<br>With the value of GLS function via echocardiography study decreased >15%, No intervention | |
| Experimental: GLS function descending >15%, Rescue therapy<br>Sacubitril/Valsartan (25/80) mg twice a day for 1 year | Drug: Rescue therapy<br>* Sacubitril/Valsartan (25/80) mg twice a day for 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain | Left ventricular global peak systolic longitudinal strain by cardiac echo | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricular ejection fraction value measured by echocardiography | Left ventricular ejection fraction by cardiac echo | 1 year | 
| Heart failure hospitalization | admission due to heart function deterioration | 1 year | 
| All-cause mortality | All types of death | 1 year | 
| Change in cardiac biomarkers: including N terminal pro B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac Troponin (hs-cTnT) | Cardiac biomarkers (NT-proBNP and hs-cTnT) changes | 1 year |