Study on Dapagliflozin to Reduce Heart Damage from Chemotherapy in Breast Cancer Patients

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What is this study about?

This clinical trial is focused on studying the effects of a medication called dapagliflozin on heart health in patients with breast cancer who are receiving certain types of chemotherapy. The chemotherapy treatments being studied include those based on anthracycline, with or without the addition of trastuzumab. These treatments can sometimes lead to heart problems, known as chemotherapy-induced cardiotoxicity, which is the main concern of this study.

The purpose of the study is to see if taking dapagliflozin can help reduce the risk of developing heart issues during and after chemotherapy. Participants in the study will be randomly assigned to receive either dapagliflozin or a placebo. The study will last for 18 months, during which time participants will be monitored for any signs of heart problems, both those that cause symptoms and those that do not.

This trial is being conducted to explore the potential protective role of SGLT-2 inhibitors, a class of medications that includes dapagliflozin, in preventing heart damage caused by chemotherapy. The study aims to provide valuable insights into whether this medication can help maintain heart health in patients undergoing treatment for breast cancer.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. This means you will have an equal chance of receiving either the study medication or a placebo, which is a pill that looks like the medication but has no active ingredients.

You will be informed about the group you are in and will receive detailed instructions on how to take the medication.

2 medication administration

If you are in the group receiving the study medication, you will take Forxiga 10 mg film-coated tablets by mouth. This medication contains the active substance dapagliflozin.

The tablets should be taken once daily, at the same time each day, for a duration of 18 months.

3 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and assess the effects of the medication. These check-ups will include physical examinations, blood tests, and heart function tests.

The frequency of these check-ups will be determined by the study team and communicated to you in advance.

4 reporting symptoms

You will be asked to report any symptoms or side effects you experience during the study. This information is important for assessing the safety and effectiveness of the medication.

You will be provided with contact information for the study team, who will be available to address any concerns or questions you may have.

5 end of study participation

At the end of the 18-month period, your participation in the study will conclude. You will have a final check-up to assess your health and gather any remaining data needed for the study.

You will be informed about the results of the study and any potential next steps regarding your treatment.

Who Can Join the Study?

Patients who have not received chemotherapy before and are scheduled to receive treatment with anthracycline with or without trastuzumab for stage I-III breast cancer.
Adult women between 18 and 70 years of age.
eGFR greater than 25 ml/min/1.7 m². eGFR is a test that measures how well your kidneys are working.
ECOG score between 0 and 2. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, while 2 means the patient is up and about more than half the day.
Consent form must be signed.
Female patients who can have children (not surgically sterilized and between the start of menstruation and 1 year after menopause) must have a negative pregnancy test result within 7 days before starting the study and on the day of the first study treatment.
Women who can have children must agree to use highly effective birth control methods from the time they give consent to participate in the study until 7 months after the last dose of the study drug.

Who Cannot Join the Study?

Patients who have a history of severe heart problems not related to chemotherapy.
Patients with uncontrolled high blood pressure.
Patients with severe kidney disease.
Patients with severe liver disease.
Patients who are pregnant or breastfeeding.
Patients who are currently participating in another clinical trial.
Patients with a known allergy to the study medication, dapagliflozin.
Patients with a history of alcohol or drug abuse.
Patients with any other medical condition that the study doctors believe would make it unsafe to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord	Pesaro	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Alessandro Manzoni Hospital	Lecco	Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Ardpgvo Ujf Tzuraqr nedx oozzx	Leghorn	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	19.10.2023

Trial locations

Investigated drugs:

Dapagliflozin

Dapagliflozin is a medication that is being tested in this study to see if it can help protect the heart from damage caused by chemotherapy in people with breast cancer. Chemotherapy can sometimes harm the heart, and this study is looking at whether taking dapagliflozin can reduce this risk. Dapagliflozin is usually used to help control blood sugar levels in people with diabetes, but researchers are exploring its potential benefits for heart health in this trial.

Trastuzumab is a medication used in the treatment of breast cancer. It works by targeting specific cancer cells and stopping them from growing. In this study, trastuzumab is part of the standard chemotherapy treatment that some participants will receive. The researchers are interested in seeing how the addition of dapagliflozin might affect the heart health of participants who are also receiving trastuzumab as part of their cancer treatment.

Investigated diseases:

Chemotherapy cardiotoxicity attenuation

Chemotherapy-induced cardiotoxicity – This condition occurs when chemotherapy drugs used in cancer treatment, particularly breast cancer, cause damage to the heart muscle. The damage can lead to a decrease in the heart’s ability to pump blood effectively, which may result in symptoms such as fatigue, shortness of breath, and swelling in the legs. The progression of cardiotoxicity can vary, with some individuals experiencing mild effects while others may develop more severe heart problems. Over time, the heart’s function may continue to decline if the condition is not managed. The risk and severity of cardiotoxicity can depend on the type and dose of chemotherapy drugs used, as well as individual patient factors. Monitoring heart function during and after chemotherapy is important to detect any changes early.

Trial ID:

2024-518611-18-00

NCT ID:

NCT06341842

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Dapagliflozin to Reduce Heart Damage from Chemotherapy in Breast Cancer Patients

What is this study about?

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