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

Breast Cancer Clinical Trial

— EMBRACE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04467411
• Other study ID #: 2-049-18
• Status: Active, not recruiting
• Start date: February 1, 2020
• Est. completion date: August 30, 2030

Study information

• Verified date: December 2023
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiomyopathies

Locations

Country	Name	City	State
United Kingdom	Cardiovascular Research Facility	Aberdeen	Aberdeenshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

References & Publications (25)

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Perry CG, Lally J, Holloway GP, Heigenhauser GJ, Bonen A, Spriet LL. Repeated transient mRNA bursts precede increases in transcriptional and mitochondrial proteins during training in human skeletal muscle. J Physiol. 2010 Dec 1;588(Pt 23):4795-810. doi: 10.1113/jphysiol.2010.199448. Epub 2010 Oct 4. — View Citation

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Zamorano JL, Lancellotti P, Rodriguez Munoz D, Aboyans V, Asteggiano R, Galderisi M, Habib G, Lenihan DJ, Lip GYH, Lyon AR, Lopez Fernandez T, Mohty D, Piepoli MF, Tamargo J, Torbicki A, Suter TM; ESC Scientific Document Group. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur Heart J. 2016 Sep 21;37(36):2768-2801. doi: 10.1093/eurheartj/ehw211. Epub 2016 Aug 26. No abstract available. Erratum In: Eur Heart J. 2016 Dec 24;: — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

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