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Trial Title:
Effect of Montelukast on Doxorubicin Induced Cardiotoxicity in Breast Cancer
NCT ID:
NCT05959889
Condition:
Breast Cancer
Doxorubicin Induced Cardiotoxicity
Conditions: Official terms:
Breast Neoplasms
Cardiotoxicity
Montelukast
Conditions: Keywords:
Montelukast
Doxorubicin
Induced Cardiotoxicity
Breast cancer Patients
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
prospective, double blind randomized (1:1) controlled trial
Intervention:
Intervention type:
Other
Intervention name:
Placebo
Description:
Patients will receive placebo tablets for 4 cycles of AC.
Arm group label:
Placebo Group
Other name:
Placebo tablet
Intervention type:
Drug
Intervention name:
Montelukast
Description:
Patients will receive motelukast 10 mg for 4 cycles of AC.
Arm group label:
Motelukast Group
Other name:
Montelukast tablet
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Damanhour Oncology Center
Address:
City:
Damanhūr
Zip:
31527
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Rehab H Werida, Ass. Prof.
Phone:
01005359968
Email:
rehabwrieda@pharm.dmu.edu.eg
Contact backup:
Last name:
Noha El Bassiouny, Lecturer
Email:
noha.el.bassiouny@pharm.dmu.edu.eg
Investigator:
Last name:
Naglaa Fathy, bachelor
Email:
Principal Investigator
Start date:
March 1, 2023
Completion date:
October 1, 2024
Lead sponsor:
Agency:
Damanhour University
Agency class:
Other
Source:
Damanhour University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05959889
