Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Recruiting · NCT07137793 · Interventional (participants receive a specific treatment) · Lead sponsor: Tanta University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 are: 1. What is the change in ejection fraction (primary outcome) in breast cancer patients receiving pentoxifylline compared to those who do not? 2. What are the changes in serum levels of N-terminal pro-B-type natriuretic peptide (NT-pro-BNP), and TNF-α (secondary outcomes) in breast cancer patients receiving pentoxifylline compared to those who do not? Researcher will compare breast cancer patients receiving standard chemotherapy alone (Group one: Positive control group; n=23) to breast cancer patients receiving standard chemotherapy plus pentoxifylline (Group two: pentoxifylline group; n=23) to see if pentoxifylline mitigates the cardiac side effects associated with doxorubicin treatment. Participants will: Be randomized to receive either a chemotherapeutic regimen alone or with pentoxifylline.
Who can take part
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.
- 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.
Where it is running
1 location listed.
- Damnhour Oncology Center - Damanhūr, Egypt