Actively Recruiting
Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Led by Tanta University · Updated on 2025-08-22
46
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Chemo-na�efve patients with biopsy confirmed diagnosis of breast cancer stage I-III
- Planned to receive at least 4 cycles of doxorubicin or more
- Performance status less than 2 by ECOG score
- Echocardiographic LVEF 55% or higher
- Adequate hematologic values (ANC � 1.5 x 10^9/L, platelet count � 90 x 10^9/L, hemoglobin � 10 g/dl)
- Adequate liver and renal function
- Signed informed consent to participate
You will not qualify if you...
- Age less than 18 years or over 65 years
- History of breast cancer
- Previously treated with doxorubicin
- Known allergy to any study drugs
- Use of blood thinners in 6 months prior to screening
- Use of NSAIDs like ketorolac or ibuprofen
- Use of other cardioprotective medications
- Pregnancy or breastfeeding
- Alcohol abuse
- Creatinine clearance less than 50 mL/min
- History of heart failure or LVEF less than 50%
- Cardiac conditions such as angina pectoris, valvular disease, uncontrolled hypertension, coronary heart disease, or cardiac surgery within last 3 months
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Trial Site Locations
Total: 1 location
1
Damnhour Oncology Center
Damanhūr, Egypt
Actively Recruiting
Research Team
S
sondos mahmoud elfeky, bachelor degree in pharmacy
CONTACT
S
Sahar kamal Hegazy professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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