Breast Cancer, Doxorubicin Induced Cardiotoxicity
Conditions
Keywords
pentoxyfillne, breast cancer, cardioprotective, Doxorubicin Induced Cardiotoxicity
Brief 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.
Interventions
patient will receive standard chemotherapy for breast cancer plus pentoxifylline 400 mg orally 3 times per day with meals.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in ejection fraction | 3 MONTHS |
Secondary
| Measure | Time frame |
|---|---|
| changes in serum levels of the measured biological markers | 3 MONTHS |
Countries
Egypt
Contacts
Primary Contactsondos mahmoud elfeky, bachelor degree in pharmacy
Backup ContactSahar kamal Hegazy professor
Outcome results
None listed