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Asthma drug may shield hearts from chemo side effect

NCT ID NCT05959889

Disease control Sponsor: Damanhour University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether montelukast, an asthma drug, can reduce heart damage caused by doxorubicin chemotherapy in breast cancer patients. Fifty adults with breast cancer were randomly assigned to receive either montelukast or a placebo alongside their treatment. Researchers measured heart stress markers in the blood before and after treatment to see if montelukast offered protection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm doxorubicin induced cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Doxorubicin induced cardiotoxicity

Contacts and locations

Locations

  • Damanhour Oncology Center

    Damanhūr, Elbehairah, 31527, Egypt

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