Clinical Study to Evaluate The Cardioprotective Effect of Pentoxifylline Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients (PTX / BC)

Tanta University

Status and phase

Enrolling

Phase 2

Conditions

Breast Cancer

Doxorubicin Induced Cardiotoxicity

Treatments

Drug: Pentoxifylline 400mg plus chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07137793

TP/RE/5/25M-006

Details and patient eligibility

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:

What is the change in ejection fraction (primary outcome) in breast cancer patients receiving pentoxifylline compared to those who do not?
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.

Enrollment

46 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.