Breast Cancer Clinical Trial
— EMBRACEOfficial title:
Randomised Controlled Study of Physical Exercise Intervention in Breast Cancer Patients at Risk of Anthracycline-induced Cardiomyopathy:The EMBRACE Study
Verified date | December 2023 |
Source | University of Aberdeen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 12 |
Est. completion date | August 30, 2030 |
Est. primary completion date | August 30, 2030 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cardiovascular Research Facility | Aberdeen | Aberdeenshire |
Lead Sponsor | Collaborator |
---|---|
University of Aberdeen |
United Kingdom,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac Energetics | Cardiac MRI and MRS | At baseline | |
Primary | Cardiac Energetics | Cardiac MRI and MRS | Through study completion, up to sixteen weeks | |
Secondary | Cardiac Imaging | Echocardiography | At baseline | |
Secondary | Cardiac Imaging | Echocardiography | Through study completion, up to sixteen weeks | |
Secondary | Blood Biomarkers | BNP and Troponins | At baseline | |
Secondary | Blood Biomarkers | BNP and Troponins | Through study completion, up to sixteen weeks | |
Secondary | Histology | Histology of skeletal muscle biopsies | At baseline | |
Secondary | Histology | Histology of skeletal muscle biopsies | Through study completion, up to sixteen weeks |
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