Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
70 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-02-01
Study Completion Date
2030-08-30
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.
Conditions
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Breast Cancer
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Breast Cancer Group
Breast Cancer Group
No interventions assigned to this group
Healthy Volunteer
Healthy Volunteer Group
No interventions assigned to this group
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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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University of Aberdeen
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Dana Dawson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Aberdeen
Locations
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Cardiovascular Research Facility
Aberdeen, Aberdeenshire, United Kingdom
Site Status
RECRUITING
Countries
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United Kingdom
Central Contacts
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Facility Contacts
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Maheshi Gunasekara, MD
Role: primary
Amelia Rudd, MSc
Role: backup
References
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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.
Reference Type
BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
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BACKGROUND
Octavia Y, Tocchetti CG, Gabrielson KL, Janssens S, Crijns HJ, Moens AL. Doxorubicin-induced cardiomyopathy: from molecular mechanisms to therapeutic strategies. J Mol Cell Cardiol. 2012 Jun;52(6):1213-25. doi: 10.1016/j.yjmcc.2012.03.006. Epub 2012 Mar 21.
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BACKGROUND
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BACKGROUND
Gamble DT, Ross J, Khan H, Unger A, Cheyne L, Rudd A, Saunders F, Srivanasan J, Kamya S, Horgan G, Hannah A, Baliga S, Tocchetti CG, Urquhart G, Linke WA, Masannat Y, Mustafa A, Fuller M, Elsberger B, Sharma R, Dawson D. Impaired Cardiac and Skeletal Muscle Energetics Following Anthracycline Therapy for Breast Cancer. Circ Cardiovasc Imaging. 2023 Oct;16(10):e015782. doi: 10.1161/CIRCIMAGING.123.015782. Epub 2023 Oct 17.
Reference Type
DERIVED
Other Identifiers
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2-049-18
Identifier Type: -
Identifier Source: org_study_id