Study on Empagliflozin to Prevent Heart Damage in Cancer Patients Receiving Anthracycline Chemotherapy

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What is this study about?

This clinical trial is focused on studying the prevention of heart damage, known as cardiotoxicity, in patients with cancer who are undergoing chemotherapy treatments that include high doses of drugs called anthracyclines. These drugs, such as doxorubicin and epirubicin, are commonly used in cancer treatment but can sometimes affect the heart. The study will use a medication called empagliflozin, which is being tested to see if it can help protect the heart during these treatments.

The purpose of the study is to evaluate how effective and safe empagliflozin is in preventing heart problems in cancer patients receiving these chemotherapy drugs. Participants in the study will be randomly assigned to receive either empagliflozin or a placebo, which looks like the medication but does not contain any active ingredients. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, ensuring unbiased results.

Throughout the study, participants will take the medication or placebo orally in the form of film-coated tablets. The study will monitor the participants over a period of time to observe any changes in heart function and to check for any side effects. The main focus will be on whether empagliflozin can prevent a decrease in the heart’s ability to pump blood effectively, which is a common issue with high doses of anthracyclines. The study aims to provide valuable information on whether this medication can be a helpful addition to cancer treatment plans to protect heart health.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, cancer diagnosis, and heart health status.

Participants must provide informed consent and agree to use effective contraception if applicable.

2 randomization

Participants are randomly assigned to receive either empagliflozin 10 mg or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

3 medication administration

The assigned medication, either Jardiance 10 mg film-coated tablets or a placebo, is taken orally once daily.

The duration of medication administration aligns with the chemotherapy treatment schedule involving high doses of anthracyclines.

4 monitoring and assessments

Regular monitoring includes echocardiography to assess heart function, specifically the left ventricular ejection fraction (LVEF).

Blood samples are collected to measure biomarkers such as Troponin T and NTproBNP, which help evaluate heart health.

5 evaluation of outcomes

The primary outcome is the time to the first event of left ventricular systolic dysfunction, identified by a significant reduction in LVEF.

Secondary outcomes include overall response rate, incidence of adverse events, and changes in heart structure and function.

6 completion of the study

The study is estimated to conclude by February 2028, with ongoing assessments and data collection throughout the trial period.

Who Can Join the Study?

Patients must have an ECOG performance status from 0 to 2. This is a scale used to assess how a patient’s disease is progressing and how the disease affects their daily living abilities.
Patients must be at least 18 years old at the time of signing the informed consent.
Patients must have a known neoplastic disease before starting chemotherapy with a high dose of anthracyclines. Neoplastic disease refers to cancer.
Patients must not have a history of heart failure, and their left ventricular ejection fraction must be 50% or higher. This is a measure of how well the heart is pumping blood.
Patients must be able to give written informed consent and follow the study’s requirements.
Women of child-bearing age must have a negative pregnancy test, either from blood or urine.
All males and females must agree to use effective contraception during the study and after stopping the study medication.
Women of childbearing potential must use two effective methods of contraception, such as abstinence, an IUD, oral contraceptives, or a double barrier device, from the time they give consent and for at least 6 months after stopping the study drug. They must also agree not to donate eggs for reproduction during this time.
Sexually active men and their partners must use effective contraception from the time they sign the informed consent and for at least 3 months after stopping the study drug.

Who Cannot Join the Study?

Patients with a history of heart failure cannot participate. Heart failure is when the heart doesn’t pump blood as well as it should.
Patients with a left ventricular (LV) ejection fraction (EF) less than 50% are excluded. The LV ejection fraction is a measurement of how much blood the left ventricle of the heart pumps out with each contraction.
Patients not scheduled for high doses of anthracyclines, which are specific cancer treatment drugs, cannot join. High doses are defined as doxorubicin 240 mg/m² or more, or epirubicin 360 mg/m² or more.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Ncrvirax Iinvcclq Orqvpiyme Ijj Mdqqo Sdlstvbgocjcbowpilpklnleqnue Ipyzmmoc Bzmwycby	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	30.09.2023

Trial locations

Investigated drugs:

Empagliflozin

Empagliflozin is a medication being studied for its potential to protect the heart in cancer patients who are receiving chemotherapy treatments that include anthracyclines. Anthracyclines are a type of chemotherapy that can sometimes cause damage to the heart. This study is looking at whether empagliflozin can help prevent this kind of heart damage, known as cardiotoxicity, by maintaining the heart’s ability to pump blood effectively.

Investigated diseases:

Chemotherapy cardiotoxicity attenuation

Cardiotoxicity – Cardiotoxicity refers to damage to the heart muscle, which can occur as a side effect of certain cancer treatments, particularly high doses of anthracyclines like doxorubicin or epirubicin. This condition can lead to a decrease in the heart’s ability to pump blood effectively, known as left ventricular dysfunction. Patients may initially have a normal heart function, but over time, the heart’s pumping ability can be compromised, leading to symptoms such as fatigue, shortness of breath, and fluid retention. The progression of cardiotoxicity can vary, with some individuals experiencing mild effects while others may develop more severe heart issues. Monitoring heart function during and after cancer treatment is crucial to detect any changes early.

Trial ID:

2024-515495-13-00

Protocol code:

2021/ABM/03/00012

NCT ID:

NCT05271162

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Empagliflozin to Prevent Heart Damage in Cancer Patients Receiving Anthracycline Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?