RecruitingPhase 2NCT07137793

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


Sponsor

Tanta University

Enrollment

46 participants

Start Date

May 25, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a drug called pentoxifylline can protect the heart from damage caused by doxorubicin, a common chemotherapy drug used to treat breast cancer. Heart damage is a known side effect of doxorubicin, and this trial aims to see if pentoxifylline can reduce that risk. **You may be eligible if...** - You are 18 to 65 years old - You have been newly diagnosed with stage I, II, or III breast cancer (confirmed by biopsy) - You have not yet received any chemotherapy - You are planned to receive at least 4 cycles of doxorubicin - Your heart function (ejection fraction) is at or above normal (≥55%) on an echocardiogram - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have a history of heart disease or a previous heart attack - You have stage IV (metastatic) breast cancer - You have significant liver or kidney problems - You are pregnant or breastfeeding - You have a known allergy to pentoxifylline Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPentoxifylline 400mg plus chemotherapy

patient will receive standard chemotherapy for breast cancer plus pentoxifylline 400 mg orally 3 times per day with meals.


Locations(1)

Damnhour Oncology Center

Damanhūr, Egypt

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NCT07137793


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