Sodium-glucose Transporter Type 2 Inhibition in Anthracycline-related Cardiotoxicity
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorUniversity of Aberdeen
About this trial
Cardiotoxicity is heart damage that arises from certain drugs, such as those used for cancer treatment and develops in approximately 10% of patients with breast cancer who are treated with anthracyclines. It has been suggested that sodium-glucose transporter-2 (SGLT2) inhibitors may reduce the damage to the heart caused by anthracycline chemotherapy. The investigators wish to determine whether dapagliflozin (SGLT2 inhibitor) taken daily during chemotherapy will reduce the rate of cardiotoxicity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with breast cancer between 18-70 years of age.
Patients with low to medium cardiovascular risk.
Patients scheduled for adjuvant or neo-adjuvant anthracycline therapy.
Patients who are able to give written informed consent to take part in the study.
Disqualifiers
Patients with a known intolerance of dapagliflozin
Patients with high cardiovascular risk as specified by the most recent cardio-oncology guidelines.
Patients with significant renal impairment (estimated glomerular filtration rate <45 mL/min/1.73 m2).
Patients with a previous cancer diagnosis.
Trial design
Design model
Parallel
Treatments tested in this trial
Sodium-glucose transport-2 (SGLT-2) inhibitors
DrugDapagliflozin 10mg in addition to standard clinical care
Standard medical treatment
Other interventionStandard clinical care
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Sodium-glucose transporter type 2 inhibition treatment armActive comparator 1 intervention
Group B: Standard clinical care placebo treatment armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cardiac energetics
In vivo myocardial phosphocreatine/gamma-adenosine triphosphate (PCr/yATP) ratio by cardiac 31P cardiac magnetic resonance spectroscopy
Time frame
From enrolment to the end of treatment at the end of approximately 22 weeksSecondary outcomes
1
Myocardial Ca2+ influx
Myocardial Ca2+ influx assessed with manganese-enhanced magnetic resonance imaging (MEMRI)
Time frame
From enrolment to the end of treatment at the end of approximately 22 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aberdeen
Lead sponsor
NHS Grampian
Collaborator
Source ClinicalTrials.gov