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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Egypt
Damnhour Oncology Center
RECRUITING
Damanhūr
Contact Information
Primary
sondos mahmoud elfeky, bachelor degree in pharmacy
sonddoselfiqy@gmail.com
01148031701
Backup
Sahar kamal Hegazy professor
Time Frame
Start Date: 2025-05-25
Estimated Completion Date: 2026-12
Participants
Target number of participants: 46
Treatments
No_intervention: Positive control group receiving standard chemotherapy for breast cancer .
Active_comparator: Pentoxifylline 400mg plus chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov