Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Antineoplastic Agents

All Drugs and Chemicals

Respiratory System Agents

Doxorubicin

Liposomal doxorubicin

Montelukast

Anti-Asthmatic Agents

Leukotriene Antagonists

Hormones

Hormone Antagonists

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

Patients will receive placebo tablets for 4 cycles of AC.

Placebo

Rehab H Werida, Ass. Prof.

Naglaa Fathy, Bachlor

Noha El Bassiouny, Lecturer

Naglaa Fathy, bachelor

Noha A. El bassiouny, Lecturer

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.

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 About 5 ml of venous blood will be withdrawn by antecubital venipuncture from each participant at baseline and after receiving montelukast 10 mg once daily at bed time for 4 cycles of AC.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

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

prospective, double blind randomized (1:1) controlled trial

Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer

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

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

Damanhour University

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer	NCT05959889	Breast Cancer Doxorubicin Ind...	Placebo Montelukast	18 Years - 70 Years	Damanhour University
Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer	NCT05959889	Breast Cancer Doxorubicin Ind...	Placebo Montelukast	18 Years - 70 Years	Damanhour University

Spots Global Cancer Trial Database for doxorubicin induced cardiotoxicity