Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer

March 5, 2026 updated by: Rehab Werida, Damanhour University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 About 5 ml of venous blood will be withdrawn by antecubital venipuncture from each participant at baseline and after receiving montelukast 10 mg once daily at bed time for 4 cycles of AC.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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elbehairah
      • Damanhūr, Elbehairah, Egypt, 31527
        • Damanhour Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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
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.
Other Names:
  • AC regimen
Active Comparator: Motelukast Group
Motelukast Group will receive motelukast 10 mg daily for 4 cycles of the same AC regimen.
Drug: Montelukast
Patients will receive motelukast 10 mg once daily for 4 cycles of AC regimen.
Other Names:
  • Montelukast tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NF-KB
Time Frame: 6 months
serum concentration of the NF-KB (ng/dl)
6 months
pro-BNP
Time Frame: 6 months
serum concentration of the pro-BNP (ng/dl)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Investigators

  • Study Director: Noha A. El bassiouny, Lecturer, Damanhour University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

July 16, 2023

First Submitted That Met QC Criteria

July 16, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Montelukast in Breast cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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