Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction

National Cheng-Kung University

Status: Enrolling

Conditions: Cardiotoxicity; Breast Cancer; Chemotherapeutic Toxicity; Lymphoma; Heart Failure

Treatments: Drug: Prevention therapy; Drug: Rescue therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05892146

A-BR-110-021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups

Prevention therapy

Experimental group

Description:

Sacubitril/Valsartan (25/80) mg twice a day for 1 year

Treatment:

Drug: Prevention therapy

Conventional therapy

No Intervention group

Description:

No intervention

Global longitudinal strain (GLS) function decreased >15%, No intervention

No Intervention group

Description:

With the value of GLS function via echocardiography study decreased \>15%, No intervention

GLS function descending >15%, Rescue therapy

Experimental group

Description:

Sacubitril/Valsartan (25/80) mg twice a day for 1 year

Treatment:

Drug: Rescue therapy