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Trial Title:
Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction
NCT ID:
NCT05892146
Condition:
Chemotherapeutic Toxicity
Cardiotoxicity
Heart Failure
Breast Cancer
Lymphoma
Conditions: Official terms:
Cardiotoxicity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Prevention therapy
Description:
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
Arm group label:
Prevention therapy
Intervention type:
Drug
Intervention name:
Rescue therapy
Description:
Sacubitril/Valsartan (25/80) mg twice a day for 1 year
Arm group label:
GLS function descending >15%, Rescue therapy
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.
Criteria for 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
Gender:
All
Minimum age:
20 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Ping-Yen Liu, PhD
Phone:
+886-6-2353535
Phone ext:
3656
Email:
larry@mail.ncku.edu.tw
Contact backup:
Last name:
Pei-Tien Hsu
Phone:
+886-6-2353535
Phone ext:
4602
Email:
sz2137@yahoo.com.tw
Start date:
May 5, 2021
Completion date:
December 31, 2025
Lead sponsor:
Agency:
National Cheng-Kung University Hospital
Agency class:
Other
Source:
National Cheng-Kung University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05892146
