Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05959889
Status:
RECRUITING
Last Update Posted:
2023-08-29
First Post:
2023-07-16
Brief Title:
Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer
Sponsor:
Damanhour University
Organization:
Damanhour University
Study Overview
Official Title:
Evaluating the Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective randomized 11 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 femalemale weight kg height cm BMI kgm2 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5 About 5 ml of venous blood will be withdrawn by antecubital venipuncture from each participant at baseline and after receiving montelukast 10 mg once daily at bed time for 4 cycles of AC At each time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 4500g 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
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 femalemale weight kg height cm BMI kgm2 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 4500g 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None