Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer (NCT05959889) | Clinical Trial Compass
CompletedNot Applicable
Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer
Egypt50 participantsStarted 2023-03-01
Plain-language summary
This is a prospective, randomized (1:1) controlled trial that will be carried out on 50 patients who are candidate to evaluate the effect of montelukast on doxorubicin induced cardiotoxicity after 4 cycles of AC. Patients will be randomly allocated into two equal groups (25 patients each); group (A) for controlled (placebo), and group (B) for montelukast. Blood samples will be collected from the study subjects and analyzed for serum levels of the NF-KB and pro-BNP. Assessment of the biomarkers will be done at two time points: at baseline and after treatment with montelukast.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Adult patients (age≥18 and≤ 70years old) with biopsy-confirmed diagnosis of breast cancer according to the American Joint Committee on Cancer (TNM staging system).
✓. Patients with performance status (\<2) according to Eastern Cooperative Oncology Group (ECOG).
✓. Patients with adequate hematologic parameters (absolute neutrophil count≥1.5× 109/L, platelet count≥100× 109/L, hemoglobin level≥10 g/dl), adequate liver function (serum bilirubin\<1.5 mg/dl), and adequate renal function (serum creatinine\<1.5 mg/dl, creatinine clearance (CrCl)\>45 ml/min).
Exclusion criteria
✕. Patients who refuse to sign the written consent.
✕. If blood cell counts are too low.
✕. Severe liver problem.
✕. Recent heart attack or have severe heart problems.
✕. Previous treatment with Doxorubicin or certain other anticancer medications.
✕. Allergy to certain other anti-cancer medicines, doxorubicin hydrochloride, Cis-platin, vincristine, paclitaxel, docetaxel, foscarnet, etc.
✕. Women with evidence of metastasis at the initial assessment.
✕. Presence of clinical evidence for severe cardiac illness (angina pectoris, uncontrolled hypertension, arrhythmias, and left ventricular ejection fraction\<50%).