Compare SGLT-2 inhibitors vs DPP-4 inhibitors to prevent heart damage from doxorubicin in women with breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 4 clinical trial will compare two classes of oral medications—SGLT-2 inhibitors (dapagliflozin) and DPP-4 inhibitors (sitagliptin)—plus standard care, to see which better prevents doxorubicin-induced cardiotoxicity in adult Egyptian women with breast cancer. Eligible participants will be adults with planned anthracycline-containing chemotherapy and adequate baseline cardiac function, randomized to one of the active arms or standard care. The study is conducted at Tanta University Oncology Hospital and uses echocardiographic measures to monitor left ventricular function over follow-up. Exclusion criteria include diabetes, significant heart disease, uncontrolled infections, and other factors that could confound cardiac outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female, ≥18 years, Egyptian nationality.
2. Breast cancer (any stage) with planned anthracycline containing chemotherapy (intended cumulative DOX ≥240 mg/m² or epirubicin ≥360 mg/m² equivalents).
3. Baseline echo suitable for LVEF ≥53%.
4. Able to consent and comply with follow up.

Exclusion Criteria:

* • Type 1 and type 2 diabetes; history of diabetic ketoacidosis; pregnancy/lactation.

  * Symptomatic HF, cardiomyopathy, significant valvular disease, prior anthracycline exposure.
  * Baseline hypotension (SBP \<95 mmHg), recurrent UTIs/mycotic infections, active foot ulcer/critical limb ischemia.
  * Inflammatory diseases, liver and kidney diseases.
  * Autoimmune diseases.
  * Other type of malignancies or metastatic diseases.
  * Patients who exposed to surgery less than one month.
  * Concomitant dexrazoxane planned upfront (allowed only for rescue; documented).
  * Known hypersensitivity to study drugs.

Where it's running

• Tanta University
  Tanta, Elgharbeya, Egypt Recruiting

Study contacts

• Principal investigator: Mohamed Abdelhamid Almeldein, Professor — Tanta University
• Study coordinator: Mai Aboelyazed Elgebaly, Associate Lecturer
• Email: dr.mai.elgebaly@gmail.com
• Phone: +0201061412257

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.