Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2025-12-31

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.

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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.

Conditions

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Chemotherapeutic Toxicity Cardiotoxicity Heart Failure Breast Cancer Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prevention therapy

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

Group Type EXPERIMENTAL

Prevention therapy

Intervention Type DRUG

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

Conventional therapy

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

GLS function descending >15%, Rescue therapy

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

Group Type EXPERIMENTAL

Rescue therapy

Intervention Type DRUG

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

Interventions

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Prevention therapy

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

Intervention Type DRUG

Rescue therapy

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

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No