Cardioprotective Empagliflozin for Cancer Patients Receiving Doxorubicin

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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 can reduce cardiovascular mortality and hospitalization for heart failure in patients with heart failure with or without diabetes and current clinical trials indicate that SGLT2 inhibitors protect against heart failure outcomes and can reduce cardiac remodeling even in patients without diabetes. Empagliflozin had beneficial effects on the outcome of the cardiomyopathy and also has anti-tumor activity in animal studies, but clinical studies are still lacking. We are going to investigate the cardioprotective effect of Empagliflozin against doxorubicin induced cardiomyopathy.

Objective:

• Evaluate the prophylactic effect of using Empagliflozin "a selective inhibitor of the sodium glucose co-transporter 2 (SGLT2)" against doxorubicin induced cardiotoxicity in patients receiving doxorubicin-based chemotherapy.

• Monitor the safety of adding empagliflozin to doxorubicin-based chemotherapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

1. Chemo-naive patients with a first diagnosis of cancer and indication for first-line therapy with doxorubicin-based chemotherapy.

2. Patients intended to receive at least 4 cycles of doxorubicin or greater.

3. No previous cardiac conditions (including ischemic heart disease and clinically important congenital or acquired valvular and myocardial diseases) and taking no cardiac-related drugs.

4. An echocardiographic LVEF value ≥55%.

5. Normal hepatic and renal function (bilirubin ≤1.5 mg/dL, creatinine ≤2.0 mg/dL).

6. ECOG performance grade 0, 1 or 2.

Exclusion Criteria:

1. Hypersensitivity / Allergy to Empagliflozin.

2. Any condition that contraindicates chemotherapy (i.e., pregnancy, lactation).

3. 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.

4. Systemic hypertension, acute coronary syndrome or cardiac surgery within the last 3 months.

5. Patients with known history or current treatment with cardiotoxic agents.

6. Receiving radiation on the left side of body.

7. History of rheumatic fever

8. Alcohol abuse.

9. Current participation in any other clinical investigation.

10. End-stage renal disease or patients on dialysis.

11. Patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus.

12. Glomerular Filtration Rate <30ml/Kg/min.