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Study of dapagliflozin to prevent heart complications during lymphoma treatment in patients receiving first-line therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with different types of lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma, and T-cell lymphomas. The research examines whether a medication called dapagliflozin can protect the heart from potential damage during standard cancer treatment. Dapagliflozin belongs to a group of medications known as SGLT2 inhibitors, which are typically used to treat diabetes.

The study will test if taking dapagliflozin while receiving standard lymphoma treatment can help prevent heart-related side effects. Participants will receive either dapagliflozin or placebo tablets for 6 months while undergoing their regular cancer treatment. The medication or placebo will be taken by mouth once daily.

During the study, doctors will monitor heart function using various tests to measure how well the heart is working. These tests include examining heart muscle movement, blood flow patterns, and checking certain substances in the blood that can indicate heart health. The study will also track any heart-related symptoms that participants may experience during their treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment preparation

    You will be assigned randomly to receive either dapagliflozin or placebo (an inactive substance) through oral administration

    Your heart function will be measured to confirm that your heart's ejection fraction is at least 50%

    Basic medical tests will be performed to ensure you meet the study requirements

  2. Step 2

    Main treatment phase

    You will receive 6 cycles of standard lymphoma treatment called (R-)CHOP or (R-)CHOEP

    Throughout this period, you will take either dapagliflozin or placebo orally as prescribed

    Regular heart monitoring will be conducted using various tests including heart scans

  3. Step 3

    One-month follow-up

    One month after completing treatment, you will undergo a detailed heart examination

    The examination will measure the heart's ability to pump blood effectively

    Various heart-related measurements will be taken, including heart muscle strain and blood tests

  4. Step 4

    Ongoing monitoring

    Regular heart examinations will continue to monitor your heart function

    Tests will include heart scans, blood tests for heart markers, and electrocardiograms (ECG)

    Your breathing and physical capacity will be evaluated using a standardized assessment

    Computer tomography (CT) scans will be performed as scheduled to examine heart-related changes

Who can join the trial?

9 criteria

  • Diagnosed with one of these blood cancers: diffuse large B-cell lymphoma, follicular lymphoma, or T-cell lymphoma that does not require stem cell transplantation as first treatment
  • Planning to receive 6 cycles of standard chemotherapy treatment called (R-)CHOP or (R-)CHOEP (medications used to treat lymphoma)
  • Have a heart function test showing an ejection fraction of 50% or higher (a measure of how well your heart pumps blood)
  • Age between 18 and 80 years old
  • Able to give written permission to participate in the study
  • Able to read and understand Danish language
  • Willing to use effective birth control methods (both men and women when applicable)
  • Able to understand study requirements and follow instructions
  • Able to attend all required study visits and complete the study as planned

Who cannot join the trial?

15 criteria

  • Age below 18 years old or above 75 years old
  • Having type 1 diabetes (a condition where the body does not produce insulin)
  • History of diabetic ketoacidosis (a serious complication of diabetes with high blood sugar levels)
  • Severe kidney disease with eGFR below 30 mL/min (reduced kidney function)
  • Currently pregnant or breastfeeding
  • Known allergies to SGLT2 inhibitors (the study medication)
  • Active or recent serious infections
  • Severe heart problems including uncontrolled heart failure
  • History of frequent urinary tract infections
  • Currently taking medications that may interact with SGLT2 inhibitors
  • Unable to provide informed consent
  • Participation in another clinical trial within the last 30 days
  • History of poor compliance with medical treatments
  • Having conditions that could interfere with study participation or evaluation
  • Having hypotension (abnormally low blood pressure)
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Investigated drugs

  • Dapagliflozin

    is a medication that belongs to a group called SGLT2 inhibitors. It works by helping the kidneys remove sugar from the blood through urine. In this trial, it is being studied for its potential protective effects on the heart during cancer treatment. The medication is already approved for treating diabetes, but researchers are investigating if it can help prevent heart problems that sometimes occur during lymphoma therapy.

  • R-CHOP

    or R-CHOEP is a combination of chemotherapy medications commonly used to treat lymphoma (a type of blood cancer). This is the standard treatment that patients receive for lymphoma, and it includes several different medications given together. While effective against cancer, these medications can sometimes affect heart function, which is why researchers are studying ways to protect the heart during treatment.

What is already known about the treatment

  • Dapagliflozin

    An oral medication belonging to the class of SGLT2 (sodium-glucose cotransporter-2) inhibitors, which is taken as a tablet once daily. Originally approved for treating type 2 diabetes, it is now being studied for its potential cardioprotective effects in cancer patients undergoing chemotherapy. The medication works by blocking specific proteins in the kidneys that reabsorb glucose, leading to increased glucose excretion in urine, but recent research suggests it may also protect heart cells from damage during cancer treatment. In this clinical trial, dapagliflozin is being investigated as a preventive treatment for heart-related side effects in lymphoma patients receiving standard chemotherapy regimens.

  • R-CHOP/CHOP/CHOEP

    A combination chemotherapy regimen administered intravenously that includes cyclophosphamide, doxorubicin, vincristine, and prednisone, with or without rituximab (R) or etoposide (E). This is the standard first-line treatment for various types of lymphoma, particularly diffuse large B-cell lymphoma and other aggressive lymphomas. The treatment works by targeting and destroying rapidly dividing cancer cells through different mechanisms, including DNA damage and cell death induction. While highly effective against lymphoma, one of its components (doxorubicin) can potentially cause heart-related side effects, which is why cardioprotective strategies are being investigated.

Investigated diseases

  • Diffuse large B-cell lymphoma

    A fast-growing cancer that affects white blood cells called B lymphocytes. It develops in the lymph nodes and can spread to other parts of the body. The disease causes enlarged lymph nodes and may affect organs like the spleen, liver, or bone marrow.

  • Follicular lymphoma Grade 3b

    A type of blood cancer that begins in the lymphatic system, specifically affecting B lymphocytes. It is characterized by a specific pattern of growth in lymph nodes. Grade 3b indicates a more aggressive form of the disease.

  • Anaplastic large T-cell lymphoma (ALK positive)

    A rare type of lymphoma that develops from T-cells carrying a specific protein marker called ALK. The disease typically affects lymph nodes and can involve skin, bones, and other organs.

  • Follicular lymphoma grade 1-3a

    A slow-growing blood cancer that develops from B lymphocytes in the lymphatic system. The grading indicates how the cells look under microscope, with grades 1-3a representing different levels of cell appearance changes. It primarily affects lymph nodes.

  • T-cell lymphomas

    A group of blood cancers that develop from T lymphocytes. These lymphomas can occur in various parts of the body, affecting lymph nodes and other organs. The disease causes abnormal growth and function of T-cells in the immune system.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521205-41-00Protocol codeDACALYEstimated enrolment74 patientsSponsorAalborg University Hospital

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