Status:
RECRUITING
Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Lead Sponsor:
Tanta University
Conditions:
Doxorubicin Induced Cardiotoxicity
Breast Cancer
Eligibility:
FEMALE
18-60 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the cardioprotective effect of pentoxifylline against doxorubicin-induced cardiotoxicity in breast cancer patients. The main questions it aims to answer ...
Eligibility Criteria
Inclusion
- 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
- Age \<18 years old and \>65 years old.
- Women with history of breast cancer.
- Formerly treated with DOX.
- Patients with a known hypersensitivity to any of the used drugs.
- Treatment with blood thinners for 6 months prior to the screening.
- Treatment with NSAIDS like ketorolac,ibuprofen.
- Patients taking any other cardioprotective medications.
- Pregnancy and breast feeding.
- Alcohol abuse.
- Creatine Clearance \< 50 mL/min.
- 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.
Key Trial Info
Start Date :
May 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT07137793
Start Date
May 25 2025
End Date
December 1 2026
Last Update
August 22 2025
Active Locations (1)
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1
Damnhour Oncology Center
Damanhūr, Egypt