Actively Recruiting

Phase 2
Age: 18Years - 65Years
FEMALE
NCT06427226

Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity

Led by Tanta University · Updated on 2026-04-17

46

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Chemo-nafve patients with biopsy confirmed diagnosis of breast cancer at stage I-III according to the TNM system
  • Patients planned to receive at least 4 cycles of doxorubicin chemotherapy
  • Performance status less than 2 based on Eastern Cooperative Oncology Group (ECOG) score
  • Echocardiographic left ventricular ejection fraction 55% or higher
  • Adequate baseline blood counts (neutrophils 21.5 x 10^9/L, platelets 21 90 x 10^9/L, hemoglobin 21 10 g/dl)
  • Adequate liver and kidney function
  • Signed informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Age less than 18 or greater than 65 years
  • Previous anthracycline treatment within the last 6 months
  • Evidence of metastasis at initial assessment
  • Treatment with any SGLT-2 inhibitors within 6 months before screening
  • Use of other cardioprotective medications
  • Pregnancy or breastfeeding
  • Alcohol abuse
  • History of heart failure or left ventricular ejection fraction below 50%
  • Cardiac conditions such as angina, valvular disease, uncontrolled hypertension, coronary heart disease, or cardiac surgery in the last 3 months
  • Type 1 diabetes mellitus or diabetic ketoacidosis
  • History of stroke
  • Severe kidney impairment with glomerular filtration rate below 25 ml/min/1.73m2
  • Use of gatifloxacin due to drug interaction with dapagliflozin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical Research Institute

Alexandria, Bab Sharqi, Egypt, 21526

Actively Recruiting

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Research Team

S

Sandy Rezkallah, Bachelor

CONTACT

O

Osama M Ibrahim, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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