Pentoxifylline to protect the heart during doxorubicin chemotherapy for breast cancer

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

This study will see if giving pentoxifylline with doxorubicin chemotherapy reduces heart damage in adults with stage I–III breast cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: Tanta University (Academic / other)
• Drugs / interventions: doxorubicin, chemotherapy
• Locations: 1 site (Damanhūr)
• Trial ID: NCT07137793 on ClinicalTrials.gov

What this trial studies

This randomized Phase 2 trial will compare standard doxorubicin-containing chemotherapy alone versus the same chemotherapy plus pentoxifylline 400 mg in chemo-naïve adults with stage I–III breast cancer. Participants (about 23 per group) are randomized to receive either chemotherapy alone or chemotherapy with pentoxifylline and will be followed through at least four cycles of treatment. The primary outcome is change in left ventricular ejection fraction, and secondary outcomes include changes in NT-proBNP and TNF-α levels. Eligibility requires age 18–65, baseline LVEF ≥55%, ECOG performance status <2, and adequate organ function.

Who should consider this trial

Good fit: Adults aged 18 to 65 with biopsy-confirmed stage I–III breast cancer who are chemo-naïve, have baseline LVEF ≥55%, ECOG <2, and are planned to receive at least four cycles of doxorubicin are ideal candidates.

Not a fit: Patients older than 65, those with prior doxorubicin exposure or prior breast cancer treatment, and people with contraindications to pentoxifylline (for example recent anticoagulant use) are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, pentoxifylline could reduce doxorubicin-related drops in ejection fraction and lower biomarkers of cardiac injury, helping preserve heart function during chemotherapy.

How similar studies have performed: Other cardioprotective strategies such as dexrazoxane and certain heart failure drugs have shown benefit against anthracycline cardiotoxicity, but pentoxifylline is a less-studied approach with only limited preliminary data supporting its use.

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.

Where this trial is running

Damanhūr

• Damnhour Oncology Center — Damanhūr, Egypt (Recruiting)

Study contacts

• Study coordinator: sondos mahmoud elfeky, bachelor degree in pharmacy

Conditions Doxorubicin Induced Cardiotoxicity; Breast Cancer; pentoxyfillne; breast cancer; cardioprotective