Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer

NCT ID: NCT05959889

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-12-01

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.

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 About 5 ml of venous blood will be withdrawn by antecubital venipuncture from each participant at baseline and after receiving montelukast 10 mg once daily at bed time for 4 cycles of AC.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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo Group

group (A) will recieved placebo tablet.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Patients will receive placebo tablets for 4 cycles of AC.

Motelukast Group

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

Group Type: ACTIVE_COMPARATOR

Montelukast

Intervention Type: DRUG

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

Interventions

Placebo

Patients will receive placebo tablets for 4 cycles of AC.

Intervention Type: OTHER

Montelukast

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

Intervention Type: DRUG

Other Intervention Names

Placebo tablet; Montelukast tablet

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Werida

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noha A. El bassiouny, Lecturer

Role: STUDY_DIRECTOR

Damanhour University

Locations

Damanhour Oncology Center

Damanhūr, Elbehairah, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 27909742 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36051669 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 41034674 (View on PubMed)

Other Identifiers

Montelukast in Breast cancer

Identifier Type: -

Identifier Source: org_study_id