NCT05959889

Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer

Evaluating the Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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: 1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. 2. About 50 patients who are candidate to the study will be recruited from Damanhour Cancer Institute. 3. All participants will provide an informed consent. 4. Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected. 5. About 5 ml of venous blood will be withdrawn by antecubital venipuncture from each participant at baseline and after receiving montelukast 10 mg once daily at bed time for 4 cycles of AC. At each time point blood samples will be collected into plain test tubes and centrifuged at 4500×g for 10 min and serum will be frozen at - 80 ◦C until analysis of the biomarkers using ELISA kits. 6. Montelukast tablets will be provided on monthly intervals and the participants' adherence will be assessed through the medications refilling rate. Participants will also be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence and report any drug related adverse effects.

Conditions

• Breast Cancer
• Doxorubicin Induced Cardiotoxicity

Interventions

Type	Name	Description
DRUG	AC protocol	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.
DRUG	Montelukast	Patients will receive motelukast 10 mg once daily for 4 cycles of AC regimen.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-11-30
• Completion: 2024-12-01
• First posted: 2023-07-25
• Last updated: 2026-03-09

Locations

1 site across 1 country: Egypt