Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer

NCT05959889 | Completed DMC

• 1 other identifier: Montelukast in Breast cancer
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Doxorubicin Induced Cardiotoxicity

Keywords

Montelukast; Doxorubicin; Induced Cardiotoxicity; Breast cancer Patients

Outcome Measures

Primary Outcomes (2)

• NF-KB

  serum concentration of the NF-KB (ng/dl)

  6 months

• pro-BNP

  serum concentration of the pro-BNP (ng/dl)

  6 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

Motelukast Group will receive motelukast 10 mg daily for 4 cycles of the same AC regimen.

Drug: Montelukast

Interventions

Montelukast DRUG

Patients will receive motelukast 10 mg once daily for 4 cycles of AC regimen.

Also known as: Montelukast tablet

Motelukast Group

AC protocol DRUG

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

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patients with performance status (\<2) according to Eastern Cooperative Oncology Group (ECOG).
• 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).

You may not qualify if:

• Patients who refuse to sign the written consent.
• If blood cell counts are too low.
• Severe liver problem.
• Recent heart attack or have severe heart problems.
• Previous treatment with Doxorubicin or certain other anticancer medications.
• Allergy to certain other anti-cancer medicines, doxorubicin hydrochloride, Cis-platin, vincristine, paclitaxel, docetaxel, foscarnet, etc.
• in the last 6 months.
• Women with evidence of metastasis at the initial assessment.
• Presence of clinical evidence for severe cardiac illness (angina pectoris, uncontrolled hypertension, arrhythmias, and left ventricular ejection fraction\<50%).
• Pregnant and breast-feeding women.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Damanhour Oncology Center

Damanhūr, Elbehairah, 31527, Egypt

Location

Related Publications (3)

• Said 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 BACKGROUND

• Elnoury 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 BACKGROUND

• Gomaa 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AC protocol; montelukast

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Noha A. El bassiouny, Lecturer

  Damanhour University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: prospective, single blind randomized (1:1) controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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); control group, and montelukast group.

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: July 25, 2023
• Study Start: March 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 1, 2024
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)