Investigating heart energy levels in breast cancer patients undergoing chemotherapy
Randomised Controlled Study of Physical Exercise Intervention in Breast Cancer Patients at Risk of Anthracycline-induced Cardiomyopathy:The EMBRACE Study
This study is testing how chemotherapy affects heart energy levels in breast cancer patients to see if it can help spot early signs of heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Aberdeen Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aberdeen, Aberdeenshire) |
| Trial ID | NCT04467411 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the cardiac energetic status in breast cancer patients receiving anthracycline therapy, specifically epirubicin. Researchers will utilize in vivo 31Phosphorus cardiac spectroscopy to measure heart energy levels before and after chemotherapy cycles, comparing results with healthy age and gender-matched controls. Additionally, the study will explore potential effects on skeletal muscle by examining biopsies from participants. The goal is to identify early indicators of cardiomyopathy to enable preventive measures.
Who should consider this trial
Good fit: Ideal candidates include breast cancer patients scheduled for their first cycle of anthracycline therapy.
Not a fit: Patients with contraindications to magnetic resonance scanning or those not undergoing anthracycline therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early interventions that prevent heart damage in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While there is emerging evidence regarding cardiac energetic status in other cardiomyopathies, this specific approach in breast cancer patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aberdeen, Aberdeenshire
- Cardiovascular Research Facility — Aberdeen, Aberdeenshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Dana Dawson, MD — University of Aberdeen
- Study coordinator: Maheshi Gunasekara, MD
- Email: maheshi.gunasekara1@abdn.ac.uk
- Phone: 01224559573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.