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The EMBRACE Study The EMBRACE Study

This study, called EMBRACE, is for women with breast cancer who are about to start a certain type of chemotherapy. These treatments, called anthracyclines, can sometimes weaken the heart muscle, a condition known as cardiomyopathy. This can happen in up to 10% of patients and is very serious. Currently, there's no way to prevent it. Researchers want to see if a change in the heart's energy levels happens *before* any damage shows up. If they can detect this early sign, it might open the door to finding ways to protect the heart and prevent this problem from developing in the first place. They will compare breast cancer patients with healthy volunteers to understand these changes.

At a glance

Status
Active not recruiting
Sponsor
University of Aberdeen
Enrolment target
70
Start
01 Feb 2020
Estimated completion
30 Aug 2030

What is this study about?

When you have breast cancer, some powerful chemotherapy drugs, called anthracyclines, are often used to fight the disease. While these drugs are very effective at treating cancer, they can sometimes cause a serious side effect: they can weaken your heart muscle. This condition is called cardiomyopathy, and it means your heart might not pump blood as well as it should. It can affect up to 1 in 10 patients who receive these treatments and is a very serious concern.

Currently, doctors don't have a way to stop this heart weakening from happening. The EMBRACE study aims to change that. Researchers believe that before the heart muscle starts to weaken noticeably, there might be subtle changes in its energy levels. Think of it like a car running low on fuel before the engine completely breaks down. If they can spot these energy changes early on, it could give doctors a chance to step in and protect your heart before any lasting damage occurs.

The study will involve looking at the heart's energy 'fuel' in breast cancer patients receiving a common anthracycline called epirubicin. They'll do this at the start and end of chemotherapy cycles, using a special type of MRI scan. They will also compare these results to healthy volunteers. By understanding if and when these energy shifts happen, the research hopes to pave the way for new ways to prevent heart problems caused by essential cancer treatments. They will also look at whether these chemotherapy drugs affect other muscles in the body, not just the heart.

Key takeaways

  • Looks for early signs of heart problems from breast cancer chemotherapy.
  • Hopes to find ways to protect the heart before damage occurs.
  • Compares breast cancer patients with healthy volunteers.
  • Involves special MRI scans of the heart.
  • Participation will not interrupt cancer treatment.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) woman who has recently been diagnosed with breast cancer and is about to start chemotherapy that includes a drug called anthracycline. You must be willing to understand what the study involves and agree to take part by giving your informed consent.

They are also looking for healthy adult volunteers, both men and women, who are around the same age as the patients in the study. These volunteers will also need to understand and agree to take part.

You cannot join the study if you have any metal implants or devices in your body, like a pacemaker, that would make it unsafe for you to have an MRI scan. Your doctor will check for this.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with breast cancer?
  3. Are you about to start chemotherapy including an "anthracycline" drug?
  4. Are you able to have an MRI scan (no incompatible metal implants)?
  5. Are you willing to discuss and sign a consent form?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the EMBRACE study, you will have special heart scans, called MRI scans, both before you start your chemotherapy and again after you finish. These scans use a powerful magnet and radio waves to create detailed pictures and measurements of your heart and its energy levels. You might also be asked to have a small muscle sample (biopsy) taken from another part of your body. These scans and any other assessments will be scheduled around your regular chemotherapy appointments. The total duration of your participation will depend on your chemotherapy schedule, but it will involve attending appointments for your scans at key points during and after your treatment.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information gained could greatly help future patients undergoing similar cancer treatments by finding ways to protect their hearts. The main risk involves the MRI scans; these are generally safe but require lying still in an enclosed space, which some people find uncomfortable, and they cannot be performed if you have certain metal implants. Having a muscle biopsy carries a small risk of discomfort or bruising. You are free to withdraw from the study at any time without affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Cardiac Research Office, Aberdeen Royal Infirmary
    Verified postcode
    Aberdeen, United Kingdom
  • Cardiovascular Research Facility
    Verified postcode
    Aberdeen, United Kingdom

Common questions

What is cardiomyopathy?

Cardiomyopathy is a condition where the heart muscle becomes weakened, making it harder for your heart to pump blood effectively around your body.

Why is this study important for breast cancer patients?

Some powerful chemotherapy drugs for breast cancer can unfortunately weaken the heart. This study hopes to find an early warning sign of this problem, so doctors can protect patients' hearts before damage occurs.

Will I have to stop my cancer treatment if I join?

No, this study runs alongside your normal breast cancer chemotherapy. Your cancer treatment will continue as planned.

What is an anthracycline drug?

Anthracyclines are a specific type of chemotherapy drug used to treat various cancers, including breast cancer. Epirubicin is an example of an anthracycline.

Do I have to do anything special to prepare for the MRI scans?

The study team will give you all the specific instructions needed before your MRI scans, such as removing metal objects.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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