Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients

Recruiting now · Phase 2

Conditions studied: Doxorubicin Induced Cardiotoxicity, Breast Cancer

In brief

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.

Key facts

Study ID

NCT07137793

Run by

Tanta University

People needed

46

Starts

2025-05-25

Expected to finish

2026-12-01

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Damnhour Oncology Center — Damanhūr, Egypt (enrolling)

Full record on ClinicalTrials.gov

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