Strategy Therapy on Early Phase Cancer Therapeutics-Related Cardiac Dysfunction Patients
| Registry | NCT05892146 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 100 (Estimated) |
| Sponsor | National Cheng-Kung University Hospital (Other) |
| Conditions | Chemotherapeutic Toxicity, Cardiotoxicity, Heart Failure, Breast Cancer, Lymphoma |
| Interventions | Prevention therapy, Rescue therapy (Drug) |
| Dates | start 2021-05-05, primary completion 2025-12-31 (estimated), completion 2025-12-31 (estimated), first posted 2023-06-07, last updated 2023-06-07 |
| Locations | 1 site in Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Chemotherapeutic Toxicity All trials for Cardiotoxicity All trials of Prevention therapy All trials of Rescue therapy
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Prevention therapy | Experimental | Drug: Prevention therapy | Sacubitril/Valsartan (25/80) mg twice a day for 1 year |
| Conventional therapy | No intervention | No intervention | |
| Global longitudinal strain (GLS) function decreased >15%, No intervention | No intervention | With the value of GLS function via echocardiography study decreased >15%, No intervention | |
| GLS function descending >15%, Rescue therapy | Experimental | Drug: Rescue therapy | Sacubitril/Valsartan (25/80) mg twice a day for 1 year |
Sex: All, ages: 20 Years to 65 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | Taiwan | Recruiting |