Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05892146
• Other study ID #: A-BR-110-021
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: National Cheng-Kung University Hospital
• Contact: Ping-Yen Liu, PhD.
• Phone: +8862353535
• Email: larry[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cardiotoxicity
• Chemotherapeutic Toxicity
• Heart Failure
• Lymphoma

Intervention

Drug:
• Prevention therapy
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
• Rescue therapy
Sacubitril/Valsartan (25/80) mg twice a day for 1 year

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in left ventricular ejection fraction value measured by echocardiography	Left ventricular ejection fraction by cardiac echo	1 year
Secondary	Heart failure hospitalization	admission due to heart function deterioration	1 year
Secondary	All-cause mortality	All types of death	1 year
Secondary	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