Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction

Sponsor

National Cheng-Kung University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05892146

Collaborator

(none)

100

Enrollment

Location

Arms

55.9

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapeutic Toxicity Cardiotoxicity Heart Failure Breast Cancer Lymphoma	Drug: Prevention therapy Drug: Rescue therapy	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 5, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain [1 year]
Left ventricular global peak systolic longitudinal strain by cardiac echo

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cheng Kung University Hospital	Tainan		Taiwan

Sponsors and Collaborators

National Cheng-Kung University Hospital

Investigators

Principal Investigator: Ping-Yen Liu, MD, PhD, National Cheng Kung University Hospital, Tainan, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ping-Yen Liu, Doctor/Professor, National Cheng-Kung University Hospital

ClinicalTrials.gov Identifier:

NCT05892146

Other Study ID Numbers:

A-BR-110-021

First Posted:

Jun 7, 2023

Last Update Posted:

Jun 7, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiotoxicity

Study Results

No Results Posted as of Jun 7, 2023