Randomised Controlled Study of Physical Exercise Intervention in Breast Cancer Patients at Risk of Anthracycline-induced Cardiomyopathy: The EMBRACE Study

Study Overview
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Brief Summary
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Cardiomyopathy is a condition that affects the heart muscle, whereby it becomes enlarged, thick or rigid. When the heart muscle becomes involved, it affects the pumping action of the heart. This condition can affect as many as 10% of all patients after undergoing anthracycline cancer drug therapy and unfortunately carries the worst prognosis of all cardiomyopathies. To date, there is no effective intervention that will prevent a patient from developing this condition. The research conducted will look to see if an energy imbalance in the heart predates the onset of detrimental changes to the pumping function of the heart, if this is detected then we can act earlier to prevent the pumping function deteriorating.

Detailed Description
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There is emerging cellular and experimental evidence that cardiac energetic status is reduced after anthracycline treatment, however, this has not been tested in the human heart. The researchers hypothesize that cardiac energetic status is reduced in the human heart after administration of anthracycline therapy in breast cancer patients, inline with the evidence available from all other types of cardiomyopathies. The researchers propose to use in vivo 31Phosphorus cardiac spectroscopy to measure the cardiac energetic status at the beginning and at the end of the cycles of chemotherapy in the hearts of breast cancer patients who are administered epirubicin (the most modern anthracycline to date) and compare this with the cardiac energetic status of age and gender matched healthy controls. Further, the researchers wish to explore if the myopathy-induced effect of anthracyclines extends to the skeletal muscle as well, by examining skeletal muscle biopsies in these patients.

Official Title
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Randomised Controlled Study of Physical Exercise Intervention in Breast Cancer Patients at Risk of Anthracycline-induced Cardiomyopathy:The EMBRACE Study

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient who has been diagnosed with breast cancer and has been scheduled for a first cycle of anthracycline therapy. Participant who is willing and able to give informed consent for participation in the study. Healthy (gender and age matched) volunteers willing to give informed consent for participation in the study. Exclusion Criteria: Contraindication to magnetic resonance scanning such as an implantable cardiac device.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer Group<br>Breast Cancer Group | |
| Healthy Volunteer<br>Healthy Volunteer Group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Energetics | Cardiac MRI and MRS | At baseline | 
| Cardiac Energetics | Cardiac MRI and MRS | Through study completion, up to sixteen weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Imaging | Echocardiography | At baseline | 
| Cardiac Imaging | Echocardiography | Through study completion, up to sixteen weeks | 
| Blood Biomarkers | BNP and Troponins | At baseline | 
| Blood Biomarkers | BNP and Troponins | Through study completion, up to sixteen weeks | 
| Histology | Histology of skeletal muscle biopsies | At baseline | 
| Histology | Histology of skeletal muscle biopsies | Through study completion, up to sixteen weeks |