Clinical trial · Interventional
Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer
Evaluating the Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Doxorubicin Induced Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AC protocol | Drug | — | UNRESOLVED |
| Montelukast | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Control group received 4 cycles of the AC regimen (which consisted of an intravenous (IV) infusion of DOX (dose/cycle = 60 mg/m2) administered as a slow IV push over 5-10 min, followed by an infusion of cyclophosphamide (dose/cycle = 600 mg/m2) over 30-60 min, with a 21-day interval).
- interventionNames
- Drug: AC protocol
- type
- ACTIVE_COMPARATOR
- label
- Motelukast Group
- description
- Motelukast Group will receive motelukast 10 mg daily for 4 cycles of the same AC regimen.
- interventionNames
- Drug: Montelukast
Primary outcomes (2)
- measure
- NF-KB
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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). 2. Patients with performance status (\<2) according to Eastern Cooperative Oncology Group (ECOG). 3. 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: 1. Patients who refuse to sign the written consent. 2. If blood cell counts are too low. 3. Severe liver problem. 4. Recent heart attack or have severe heart problems. 5. Previous treatment with Doxorubicin or certain other anticancer medications. 6. Allergy to certain other anti-cancer medicines, doxorubicin hydrochloride, Cis-platin, vincristine, paclitaxel, docetaxel, foscarnet, etc. in the last 6 months. 7. Women with evidence of metastasis at the initial assessment. 8. Presence of clinical evidence for severe cardiac illness (angina pectoris, uncontrolled hypertension, arrhythmias, and left ventricular ejection fraction\<50%). 9. Pregnant and breast-feeding women.
References
Publications (3)
- BACKGROUNDSaid MM, Bosland MC. The anti-inflammatory effect of montelukast, a cysteinyl leukotriene receptor-1 antagonist, against estradiol-induced nonbacterial inflammation in the rat prostate. Naunyn Schmiedebergs Arch Pharmacol. 2017 Feb;390(2):197-205. doi: 10.1007/s00210-016-1325-4. Epub 2016 Dec 1. PMID 27909742
- BACKGROUNDElnoury HA, Elgendy SA, Baloza SH, Ghamry HI, Soliman M, Abdel-Aziz EA. Synergistic impacts of Montelukast and Klotho against doxorubicin-induced cardiac toxicity in Rats. Toxicol Res (Camb). 2022 Jun 20;11(4):592-604. doi: 10.1093/toxres/tfac023. eCollection 2022 Aug. PMID 36051669
- DERIVEDGomaa NF, Werida RH, El-Gowily AG, El-Bassiouny NA. Evaluating the role of montelukast on doxorubicin-induced cardiotoxicity in breast cancer patients. Support Care Cancer. 2025 Oct 1;33(10):897. doi: 10.1007/s00520-025-09947-z. PMID 41034674