Dapagliflozin for Prevention of Chemotherapy-Induced Cardiotoxicity: a Randomized Controlled Trial

Launched by HAWLER MEDICAL UNIVERSITY · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called Dapagliflozin can help prevent heart problems caused by certain cancer treatments, specifically anthracyclines (like doxorubicin) and trastuzumab (Herceptin). These treatments can sometimes lead to heart damage, which is a serious concern for patients undergoing chemotherapy. By enrolling 100 participants who are receiving these treatments, the study aims to see if Dapagliflozin can protect the heart while still allowing the chemotherapy to work effectively.

To be eligible for the trial, participants should be between 18 and 70 years old, have a confirmed diagnosis of breast cancer or other relevant cancers, and be planning to receive anthracycline and/or trastuzumab chemotherapy. They should also have normal kidney and liver function. Throughout the study, patients will receive either Dapagliflozin or a placebo (a dummy treatment) alongside their cancer therapy, and their heart function will be monitored closely. This research is important because if successful, it could lead to better heart health for cancer patients, improving their overall quality of life during and after treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed breast cancer (or other cancers as relevant to the study).
• • Age 18-70 years.
• • Planned treatment with anthracycline-based and/or trastuzumab-based chemotherapy.
• • Normal kidney function, defined as serum creatinine 0.6-1.2 mg/dL.
• • Normal liver function, defined as ALT and AST 10-40 U/L.
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• • Willingness to participate and provide written informed consent.
• Exclusion Criteria:
• • History of symptomatic heart failure (NYHA class III-IV) or prior anthracycline-related cardiac dysfunction.
• • Previous use of Dapagliflozin.
• • Pregnancy or breastfeeding.
• • Severe renal impairment (eGFR \< 30 mL/min/1.73m²).
• • Uncontrolled diabetes mellitus (HbA1c \> 9%).
• • Active or recurrent urinary tract infections (UTIs) within the last 6 months.
• • Known hypersensitivity to Dapagliflozin or related compounds.
• • Concurrent participation in another clinical trial investigating cardioprotective agents.