Ongoing Clinical Trials for Chemotherapy Cardiotoxicity Attenuation
Currently, there are 2 clinical trials investigating ways to prevent heart damage in cancer patients receiving chemotherapy. These studies are testing medications that may help protect the heart from harmful effects of certain cancer treatments. The trials are being conducted in Poland and Italy, focusing on patients with various types of cancer who are receiving drugs called anthracyclines.
Clinical trial locations
- Italy
- Poland
Study on Empagliflozin to Prevent Heart Damage in Cancer Patients Receiving Anthracycline Chemotherapy
This trial is investigating whether a medication called empagliflozin can help protect the heart in cancer patients who are receiving high doses of anthracycline chemotherapy drugs, such as doxorubicin and epirubicin. While these drugs are effective in treating cancer, they can sometimes affect the heart’s ability to pump blood effectively.
Who can participate: The study is looking for patients who are at least 18 years old with a confirmed cancer diagnosis and who are scheduled to receive high doses of anthracyclines. Participants must have good heart function at the start, with a left ventricular ejection fraction of 50% or higher, and no previous history of heart failure. Their overall health status should allow them to carry out daily activities with minimal limitations. Women of childbearing age must have a negative pregnancy test and agree to use effective contraception throughout the study and for several months afterward.
Who cannot participate: Patients with a history of heart failure or those whose heart’s pumping ability is already reduced are excluded. The study also cannot accept patients who are not scheduled to receive the required high doses of anthracyclines.
What the study involves: Participants will be randomly assigned to receive either empagliflozin tablets or a placebo, taken once daily by mouth. Neither the participants nor the researchers will know who is receiving the actual medication, ensuring unbiased results. Throughout the trial, heart function will be regularly monitored using echocardiography, and blood tests will measure specific markers that indicate heart health. The main goal is to determine whether empagliflozin can prevent a decline in the heart’s pumping ability during cancer treatment.
The medication being tested: Empagliflozin belongs to a class of drugs called SGLT2 inhibitors, which work by affecting how the kidneys handle sugar. While typically used for managing diabetes, researchers are exploring whether it can also offer protective benefits for the heart during chemotherapy.
Study on Dapagliflozin to Reduce Heart Damage from Chemotherapy in Breast Cancer Patients
This trial focuses specifically on breast cancer patients and is testing whether dapagliflozin can reduce the risk of heart problems during and after chemotherapy. The study involves patients receiving anthracycline-based treatments, with or without the addition of trastuzumab, another cancer medication.
Who can participate: The study is recruiting adult women between 18 and 70 years of age who have stage I-III breast cancer and have not received chemotherapy before. They must be scheduled to receive anthracycline-based treatment with or without trastuzumab. Participants need to have adequate kidney function and be able to perform most daily activities. Women of childbearing potential must have a negative pregnancy test before starting and agree to use highly effective birth control methods throughout the study and for 7 months after the last dose.
Who cannot participate: Women with severe heart problems unrelated to chemotherapy, uncontrolled high blood pressure, severe kidney or liver disease, or those who are pregnant or breastfeeding cannot join. Patients with a known allergy to dapagliflozin, those currently in another clinical trial, or those with a history of substance abuse are also excluded. Any other medical condition that doctors believe would make participation unsafe will also prevent enrollment.
What the study involves: Participants will be randomly assigned to receive either dapagliflozin 10 mg tablets or a placebo, taken once daily by mouth for 18 months. During this time, they will have regular check-ups including physical examinations, blood tests, and heart function tests. Participants will be asked to report any symptoms or side effects they experience. The study aims to monitor for both symptomatic and asymptomatic heart problems that may develop during treatment.
The medication being tested: Dapagliflozin is another SGLT2 inhibitor, similar to empagliflozin, which is commonly used to manage blood sugar levels in diabetes. In this study, researchers are investigating whether it can also protect the heart from damage caused by chemotherapy drugs, particularly in combination with trastuzumab.
Summary
Both ongoing trials are exploring a similar approach to preventing heart damage in cancer patients, using medications from the SGLT2 inhibitor class. While originally developed for diabetes management, these drugs are now being investigated for their potential heart-protective effects during chemotherapy. The Polish study focuses on a broader range of cancers requiring high-dose anthracyclines, while the Italian study specifically targets breast cancer patients. Both studies use a similar design, with participants randomly receiving either the study medication or a placebo, and both emphasize careful monitoring of heart function throughout treatment. These trials represent important efforts to address one of the significant complications of cancer therapy and potentially improve outcomes for patients who need these life-saving treatments but face risks to their heart health.
