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

December 7, 2023 updated by: University of Aberdeen

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Aberdeenshire
      • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
        • Cardiovascular Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy volunteers and patients diagnosed with breast cancer who have been scheduled for the first cycle of anthracycline therapy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast Cancer Group
Healthy Volunteer
Healthy Volunteer Group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dana Dawson, MD, University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Estimated)

August 30, 2030

Study Completion (Estimated)

August 30, 2030

Study Registration Dates

First Submitted

July 2, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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