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The EMBRACE Study The EMBRACE Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04467411
Acronym
EMBRACE
Enrollment
70
Registered
2020-07-13
Start date
2020-02-01
Completion date
2030-08-30
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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

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.

Interventions

None listed

Sponsors

University of Aberdeen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac EnergeticsAt baselineCardiac MRI and MRS

Secondary

MeasureTime frameDescription
Cardiac ImagingAt baselineEchocardiography
Blood BiomarkersAt baselineBNP and Troponins
HistologyAt baselineHistology of skeletal muscle biopsies

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORDana Dawson, MD

University of Aberdeen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026