An interventional study of AC protocol and Montelukast in Breast Cancer and Doxorubicin Induced Cardiotoxicity, sponsored by Damanhour University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Damanhour University · Not applicable, Interventional, and Treatment
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.
The primary objective of this study is to evaluate the effect of montelukast on doxorubicin induced cardiotoxicity in breast cancer patients through assessing serum NT-proBNP and NF-KB. The secondary objective is to evaluate the safety and side effects of montelukast on doxorubicin induced cardiotoxicity in breast cancer patients.
Methodology and study design:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 50 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Damanhour University is the lead sponsor of 76 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Allergy to certain other anti-cancer medicines, doxorubicin hydrochloride, Cis-platin, vincristine, paclitaxel, docetaxel, foscarnet, etc.
in the last 6 months.
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).
Drug: AC protocol
Motelukast Group will receive motelukast 10 mg daily for 4 cycles of the same AC regimen.
Drug: Montelukast
The 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.
Also known as: AC regimen
Patients will receive motelukast 10 mg once daily for 4 cycles of AC regimen.
Also known as: Montelukast tablet
NF-KB
serum concentration of the NF-KB (ng/dl)
Time frame: 6 months
pro-BNP
serum concentration of the pro-BNP (ng/dl)
Time frame: 6 months
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Damanhour University