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NCT Number: NCT07137793

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

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Damnhour Oncology Center

Damanhūr, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pentoxifylline 400mg plus chemotherapy

Drug

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

Primary outcomes

  1. change in ejection fraction

    Time frame: 3 MONTHS

Secondary outcomes

  1. changes in serum levels of the measured biological markers

    Time frame: 3 MONTHS

Study contacts

Contact information is provided by the study sponsor or research team.

Sahar kamal Hegazy professor

CONTACT

sondos mahmoud elfeky, bachelor degree in pharmacy

CONTACT

[email protected]

01148031701 ext. +02

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Acronym: PTX / BC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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