Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 About 5 ml of venous blood will be withdrawn by antecubital venipuncture from each participant at baseline and after receiving montelukast 10 mg once daily at bed time for 4 cycles of AC.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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05959889
Study type	Interventional
Source	Damanhour University
Contact	Rehab H Werida, Ass. Prof.
Phone	+201005359968
Email	rehabwrieda@pharm.dmu.edu.eg
Status	Recruiting
Phase	N/A
Start date	March 1, 2023
Completion date	May 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms