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Recruiting NCT07137793

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

Phase II Interventional Doxorubicin Induced Cardiotoxicity Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pentoxifylline 400mg plus chemotherapy.
Who it may be relevant to
Registry conditions: Doxorubicin Induced Cardiotoxicity, Breast Cancer. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • change in ejection fraction [Time frame: 3 MONTHS]
Secondary outcome measures (1)
  • changes in serum levels of the measured biological markers [Time frame: 3 MONTHS]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Damnhour Oncology Center — Damanhūr

Publications

  • Matboli M, Habib EK, Hussein Mohamed R, Mahran NA, Seleem HS, Nosseir N, Hasanin AH. Pentoxifylline alleviated cardiac injury via modulating the cardiac expression of lncRNA-00654-miR-133a-SOX5 mRNA in the rat model of ischemia-reperfusion. Biomed Pharmacother. 2020 Apr;124:109842. doi: 10.1016/j.biopha.2020.109842. Epub 2020 Jan 20. PMID 31972363
  • Dezube BJ, Sherman ML, Fridovich-Keil JL, Allen-Ryan J, Pardee AB. Down-regulation of tumor necrosis factor expression by pentoxifylline in cancer patients: a pilot study. Cancer Immunol Immunother. 1993;36(1):57-60. doi: 10.1007/BF01789132. PMID 7678547
  • Fernandes JL, de Oliveira RTD, Mamoni RL, Coelho OR, Nicolau JC, Blotta MHSL, Serrano CV Jr. Pentoxifylline reduces pro-inflammatory and increases anti-inflammatory activity in patients with coronary artery disease--a randomized placebo-controlled study. Atherosclerosis. 2008 Jan;196(1):434-442. doi: 10.1016/j.atherosclerosis.2006.11.032. Epub 2006 Dec 28. PMID 17196208

Identifiers

NCT: NCT07137793 · TP/RE/5/25M-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗