NCT06427226 Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity
| NCT ID | NCT06427226 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tanta University |
| Condition | Doxorubicin Induced Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-10-31 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 46 participants in total. It began in 2024-10-31 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized controlled clinical trial that aims to evaluate the safety and efficacy of Dapagliflozin as a cardioprotective in doxorubicin-induced cardiotoxicity in breast cancer patients.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years old. * Chemo-naïve patients with biopsy confirmed diagnosis of breast cancer and with stage I-III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer). * Patients intended to receive at least 4 cycles of doxorubicin or more. * Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score. * Echocardiographic LVEF ≥55%. * Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 ×109/L, platelet count ≥ 90 × 109/L and hemoglobin level ≥ 10 g/dl). * Patients with adequate liver function and adequate renal function. * Signed informed consent to participate in the study. Exclusion Criteria: * Age \<18 years old and \>65 years old. * Patients with prior exposure to anthracyclines within the last 6 months. * Patients with evidence of metastasis at initial assessment. * Treatment with any SGLT-2 inhibitors for 6 months prior to the screening. * Patients taking any other cardioprotective medications. * Pregnancy and breast feeding. * Alcohol abuse. * History of heart failure or LVEF \<50%. * Presence of any cardiac-related conditions such as angina pectoris, valvular disease, uncontrolled systemic hypertension, coronary heart disease, and cardiac surgery within the last 3 months. * Patients with type 1 diabetes mellitus or diabetic ketoacidosis, history of stroke, and patients with severe renal impairment with GFR \<25ml/min/1.73m2 . - Patients taking gatifloxacin as it causes major drug interaction with dapagliflozin.
Contact & Investigator
Sandy E Rezkallah, bachelor
PRINCIPAL INVESTIGATOR
Tanta University
Frequently Asked Questions
Who can join the NCT06427226 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Doxorubicin Induced Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06427226 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06427226 currently recruiting?
Yes, NCT06427226 is actively recruiting participants. Contact the research team at sandyehab58@gmail.com for enrollment information.
Where is the NCT06427226 trial being conducted?
This trial is being conducted at Alexandria, Egypt.
Who is sponsoring the NCT06427226 clinical trial?
NCT06427226 is sponsored by Tanta University. The principal investigator is Sandy E Rezkallah, bachelor at Tanta University. The trial plans to enroll 46 participants.