Actively Recruiting

Phase 2
Age: 18Years - 60Years
FEMALE
Healthy Volunteers
NCT07137793

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

Age: 18Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Damnhour Oncology Center

Damanhūr, Egypt

Actively Recruiting

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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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