Evaluation of Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induc… (NCT06155331) | Clinical Trial Compass
CompletedPhase 2
Evaluation of Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Egypt44 participantsStarted 2023-12-01
Plain-language summary
This study aims at evaluating the possible safety and efficacy of fenofibrate in attenuating doxorubicin related cardiac toxicity in breast cancer patients.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion Criteria:
* Age ≥ 18 years old.
* Patients with biopsy confirmed diagnosis breast cancer and with stage II and stage III breast cancer according to the American Joint Committee on Cancer (TNM staging system of breast cancer).
* Patients with performance status \<2 according to Eastern Cooperative Oncology Group (ECOG) score.
* Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl).
* Patients with adequate liver function (serum bilirubin \< 1.2 mg/dl) and adequate renal function (serum creatinine \< 1.5 mg/d).
Exclusion Criteria:
* Patients with prior exposure to anthracyclines in the last 6 months.
* Patients with evidence of metastasis at the initial assessment.
* Concomitant use of antioxidant vitamins (vitamin A, C, E).
* Presence of clinical evidence for severe cardiac illness (angina pectoris, uncontrolled hypertension, arrhythmias and left ventricular ejection fraction \<50%).
* Patients with inflammatory diseases (ulcerative colitis, rheumatoid arthritis).
* Patients with conditions associated with oxidative stress (smoking, tuberculosis, comorbid obesity).
* Patients who are candidates for monoclonal antibodies such as Trastuzumab and other targeted therapy (HER2 positive patients).
* Patients with active liver disease (cirrhosis, fatty liver, hepatitis C, etc..).
* Patients with myopathy.
* Patients with renal impairment, including those with end-stage renal disease a…
What they're measuring
1
Assessment of changes in ejection fraction (the amount of blood that heart pumps each beat) using echocardiography