Status:
UNKNOWN
Cardioprotective Empagliflozin for Cancer Patients Receiving Doxorubicin
Lead Sponsor:
Ain Shams University
Conditions:
Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Doxorubicin induced cardiomyopathy is the most common and serious side effect associated with doxorubicin treatment in cancer patients receiving doxorubicin. Studies have been shown that Empagliflozin...
Detailed Description
In cancer therapy, several cytotoxic drugs may cause cardiotoxicity which is associated with poor short- and long-term outcome. Anthracyclines (ANT) are natural products with topoisomerase-interacting...
Eligibility Criteria
Inclusion
- Chemo-naive patients with a first diagnosis of cancer and indication for first-line therapy with doxorubicin-based chemotherapy.
- Patients intended to receive at least 4 cycles of doxorubicin or greater.
- No previous cardiac conditions (including ischemic heart disease and clinically important congenital or acquired valvular and myocardial diseases) and taking no cardiac-related drugs.
- An echocardiographic LVEF value ≥55%.
- Normal hepatic and renal function (bilirubin ≤1.5 mg/dL, creatinine ≤2.0 mg/dL).
- ECOG performance grade 0, 1 or 2.
Exclusion
- Hypersensitivity / Allergy to Empagliflozin.
- Any condition that contraindicates chemotherapy (i.e., pregnancy, lactation).
- New-onset cardiac symptoms or presence of congestive heart failure symptoms or established (dilated, restrictive or hypertrophic) cardiomyopathy, coronary heart disease, moderate or severe aortic and/or mitral valve disease or atrial fibrillation detected by baseline echocardiography.
- Systemic hypertension, acute coronary syndrome or cardiac surgery within the last 3 months.
- Patients with known history or current treatment with cardiotoxic agents.
- Receiving radiation on the left side of body.
- History of rheumatic fever
- Alcohol abuse.
- Current participation in any other clinical investigation.
- End-stage renal disease or patients on dialysis.
- Patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus.
- Glomerular Filtration Rate \<30ml/Kg/min.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06103279
Start Date
November 1 2023
End Date
August 1 2024
Last Update
October 26 2023
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