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Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction

Primary Purpose

Chemotherapeutic Toxicity, Cardiotoxicity, Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Prevention therapy
Rescue therapy
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chemotherapeutic Toxicity

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

No Intervention

Experimental

Arm Label

Prevention therapy

Conventional therapy

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

GLS function descending >15%, Rescue therapy

Arm Description

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

No intervention

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in left ventricular ejection fraction value measured by echocardiography
Left ventricular ejection fraction by cardiac echo
Heart failure hospitalization
admission due to heart function deterioration
All-cause mortality
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)
Cardiac biomarkers (NT-proBNP and hs-cTnT) changes

Full Information

First Posted
May 26, 2023
Last Updated
June 6, 2023
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05892146
Brief Title
Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction
Official Title
Strategy Therapy on Early Phase Cancer Therapeutics-Related Cardiac Dysfunction Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapeutic Toxicity, Cardiotoxicity, Heart Failure, Breast Cancer, Lymphoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prevention therapy
Arm Type
Experimental
Arm Description
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
Arm Title
Conventional therapy
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Global longitudinal strain (GLS) function decreased >15%, No intervention
Arm Type
No Intervention
Arm Description
With the value of GLS function via echocardiography study decreased >15%, No intervention
Arm Title
GLS function descending >15%, Rescue therapy
Arm Type
Experimental
Arm Description
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
Intervention Type
Drug
Intervention Name(s)
Prevention therapy
Intervention Description
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
Intervention Type
Drug
Intervention Name(s)
Rescue therapy
Intervention Description
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
Primary Outcome Measure Information:
Title
Change in absolute global longitudinal strain value measured by left ventricular global peak systolic longitudinal strain
Description
Left ventricular global peak systolic longitudinal strain by cardiac echo
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in left ventricular ejection fraction value measured by echocardiography
Description
Left ventricular ejection fraction by cardiac echo
Time Frame
1 year
Title
Heart failure hospitalization
Description
admission due to heart function deterioration
Time Frame
1 year
Title
All-cause mortality
Description
All types of death
Time Frame
1 year
Title
Change in cardiac biomarkers: including N terminal pro B type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac Troponin (hs-cTnT)
Description
Cardiac biomarkers (NT-proBNP and hs-cTnT) changes
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping-Yen Liu, PhD.
Phone
+8862353535
Ext
3656
Email
larry@mail.ncku.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Tien Hsu
Phone
+8862353535
Ext
4602
Email
sz2137@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Yen Liu, MD, PhD
Organizational Affiliation
National Cheng Kung University Hospital, Tainan, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping-Yen Liu, PhD
Phone
+886-6-2353535
Ext
3656
Email
larry@mail.ncku.edu.tw
First Name & Middle Initial & Last Name & Degree
Pei-Tien Hsu
Phone
+886-6-2353535
Ext
4602
Email
sz2137@yahoo.com.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction

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