Using Sacubitril/Valsartan to protect the heart during cancer treatment
Strategy Therapy on Early Phase Cancer Therapeutics-Related Cardiac Dysfunction Patients
This study is testing if a heart medication can help protect the hearts of breast cancer or lymphoma patients during chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tainan) |
| Trial ID | NCT05892146 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Sacubitril/Valsartan in preventing cardiac dysfunction in patients with breast cancer or lymphoma undergoing chemotherapy. Patients will be screened and enrolled from the cancer registration system at National Cheng Kung University Hospital. The trial involves two groups: one receiving the cardioprotective drug and the other receiving a placebo, with regular assessments of cardiac function before and after treatment. The goal is to determine the protective and therapeutic benefits of this intervention against chemotherapy-related cardiac toxicity.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed breast cancer or lymphoma patients aged 20-65 who have not yet received anti-cancer therapy.
Not a fit: Patients with end-stage renal disease, severe heart dysfunction, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of heart damage in cancer patients undergoing chemotherapy.
How similar studies have performed: While the approach of using cardioprotective drugs in cancer therapy is being explored, this specific strategy is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tainan
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Ping-Yen Liu, MD, PhD — National Cheng Kung University Hospital, Tainan, Taiwan
- Study coordinator: Ping-Yen Liu, PhD.
- Email: larry@mail.ncku.edu.tw
- Phone: +8862353535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.