Comparison of Mirtazapine and Olanzapine on Nausea and Vomiting following Anthracycline-Cyclophosphamide Chemotherapy Regimen in Patients with Breast Cancer
Determining the Efficacy and Safety of Two Mirtazapine and Olanzapine-based Therapeutic Regimens for the Prevention of Nausea and Vomiting following Anthracyline, Cyclophosphamide Chemotherapy Regimen in Patients with Breast Cancer
Design
Randomized Clinical Trial with Two Study Arms, with Parallel and Double blinded Groups
Settings and conduct
This clinical Trial Study will be performed on Patients with Breast Cancer admitted to the Oncology Ward of Taleghani and Baqiyatallah Hospitals in Tehran. Sixty Patients will be randomly divided into Two Intervention Groups, Mirtazapine (MTZ) and Olanzapine (OLP). Each Group will receive Triple Standard of Care Regimen before Chemotherapy in Addition to MTZ or OLP. The primary Outcomes of Nausea and Vomiting and secondary Outcomes will be measured by the NCI-CTCAE up to Five Days after Chemotherapy in the first Two Cycles.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with newly diagnosed Breast Cancer; Patients aged 18-65; Recipient of Chemotherapy Regimen for at least Two consecutive Cycles; Written informed Consent; Exclusion Criteria: A History of Allergy to Mirtazapine or Olanzapine; A History of MI, Seizures, Arrhythmias, Glaucoma and BMD; Concomitant use of any Drug with Class X and D Interference with the Drugs studied; renal or hepatic Failure
Intervention groups
Intervention Group 1: Triple Standard of Care Regimen [Aprepitant Capsule (125 mg PO OD on Day 1, 80 mg OD on Days 2-3), Granisetron (1 mg IV only on Day 1), Dexametason (12 mg IV only on Day 1)] and Mirtazapine Tablet (15 mg PO OD on Days 1-4); Intervention Group 2: Triple Standard of Care Regimen [Aprepitant Capsule (125 mg PO OD on Day 1, 80 mg OD on Days 2-3), Granisetron (1 mg IV only on Day 1), Dexametason (12 mg IV only on Day 1)] and Olanzapine Tablet (10 mg PO OD on Days 1-4).
Main outcome variables
The Severity of Nausea and Vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003210N19
Registration date:2020-02-10, 1398/11/21
Registration timing:registered_while_recruiting
Last update:2020-02-10, 1398/11/21
Update count:0
Registration date
2020-02-10, 1398/11/21
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2020-05-14, 1399/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Mirtazapine and Olanzapine on Nausea and Vomiting following Anthracycline-Cyclophosphamide Chemotherapy Regimen in Patients with Breast Cancer
Public title
“Comparison of Mirtazapine and Olanzapine on Nausea and Vomiting following Chemotherapy “
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Newly Diagnosed Breast Cancer
Receiving Anthracycline-Cyclophosphamide Chemotherapy Regimen in the adjuvant Setting for at least Two consecutive Cycles
Patients aged 18 to 65
Written Informed Consent
The Patient is able to read and understand the Questionnaires used in the Study
Exclusion criteria:
A History of Allergy to Mirtazapine or Olanzapine
Patient with History of Dementia, peptic Ulcer, myocardial Infarction, Seizure, Arrhythmia, Glaucoma, and bipolar Disorder
Concomitant use of any Drug with Class X and D Interaction with the Drugs studied
Increased basal Creatinine (SrCr ≥ 1.5) or AST or ALT ≥ 3ULN
Brain Metastasis or Metastases with gastrointestinal Obstruction
Having Nausea and Vomiting within 24 hours prior to Chemotherapy
Patients with Disabilities taking oral Medications
On chronic antiemetic Therapy (e.g.Metoclopramide); on long Term use of systemic Steroids prior to Chemotherapy
Uncontrolled Diabetes
The Patient has a History of any Illness that, in the Opinion of the Investigator, might confound the Results of the Study or pros unwarranted Risk
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Individual Randomization with the Card in Two Groups A and B, in this Way a Number of Cards are selected as the first Intervention Group and the same Number in the second Intervention Group, then by merging the Cards together one Card is drawn and its Allocation is recorded and the Card is returned to the other Cards after it has been removed. The Cards are then re-merged and another Card is withdrawn. The Process continues until a Random Sequence Sample Size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinding will be done for the Intervention.Groups will be designated as A and B, so the Principle Investigator, Outcome Assessor and Data Analyzer will not know how Patients are assigned.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti School of Pharmacy, Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-11-04, 1398/08/13
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.210
Health conditions studied
1
Description of health condition studied
Patient with breast cancer
ICD-10 code
C50.919
ICD-10 code description
Malignant neoplasm of unspecified site of unspecified female breast
Primary outcomes
1
Description
Severity of Nausea in the Group receiving Mirtazapine
Timepoint
During the Acute Phase [0-24 hours after chemotherapy (CT)], the Delayed (24-120 hours after CT) and the overall (0-120 hours after CT) phases for two CT cycles (each cycle is 21 days)
Method of measurement
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
2
Description
Severity of Nausea in the Group receiving Olanzapine
Timepoint
During the Acute Phase [0-24 hours after chemotherapy (CT)], the Delayed (24-120 hours after CT) and the overall (0-120 hours after CT) phases for two CT cycles (each cycle is 21 days)
Method of measurement
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
3
Description
Comparison of the Severity of Nausea in Two Groups receiving Mirtazapine and Olanzapine
Timepoint
During the Acute Phase [0-24 hours after chemotherapy (CT)], the Delayed (24-120 hours after CT) and the overall (0-120 hours after CT) phases for two CT cycles (each cycle is 21 days)
Method of measurement
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
4
Description
Severity of Vomiting in the Group receiving Mirtazapine
Timepoint
During the Acute Phase [0-24 hours after chemotherapy (CT)], the Delayed (24-120 hours after CT) and the overall (0-120 hours after CT) phases for two CT cycles (each cycle is 21 days)
Method of measurement
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
5
Description
Severity of Vomiting in the Group receiving Olanzapine
Timepoint
During the Acute Phase [0-24 hours after chemotherapy (CT)], the Delayed (24-120 hours after CT) and the overall (0-120 hours after CT) phases for two CT cycles (each cycle is 21 days)
Method of measurement
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
6
Description
Comparison of the Severity of Vomiting in Two Groups receiving Mirtazapine and Olanzapine
Timepoint
During the Acute Phase [0-24 hours after chemotherapy (CT)], the Delayed (24-120 hours after CT) and the overall (0-120 hours after CT) phases for two CT cycles (each cycle is 21 days)
Method of measurement
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Secondary outcomes
1
Description
Comparison of The Quality of Life in Two Groups receiving Mirtazapine and Olanzapine
Timepoint
120 Hours after Initiation of Chemotherapy
Method of measurement
18-item Functional Living Index-Emesis (FLIE) Questionnaire
2
Description
Severity of adverse Events in the Group receiving Mirtazapine
Timepoint
During the Acute Phase [0-24 Hours after Chemotherapy (CT)], the Delayed (24-120 Hours after CT) and the Overall (0-120 Hours after CT) Phases for Two CT Cycles (each Cycle is 21 Days)
Method of measurement
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
3
Description
Severity of adverse Events in The Group receiving Olanzapine
Timepoint
During the Acute Phase [0-24 Hours after Chemotherapy (CT)], the Delayed (24-120 Hours after CT) and the Overall (0-120 Hours after CT) Phases for Two CT Cycles (each Cycle is 21 Days)
Method of measurement
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
4
Description
Comparison of the Severity of adverse Events in Two Groups receiving Mirtazapine and Olanzapine
Timepoint
During the Acute Phase [0-24 Hours after Chemotherapy (CT)], the Delayed (24-120 Hours after CT) and the Overall (0-120 Hours after CT) Phases for Two CT Cycles (each Cycle is 21 Days)
Method of measurement
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
5
Description
Comparison of the Severity of Somnolence in Two Groups receiving Mirtazapine and Olanzapine
Timepoint
During the Acute Phase [0-24 Hours after Chemotherapy (CT)], the Delayed (24-120 Hours after CT) and the Overall (0-120 Hours after CT) Phases for Two CT Cycles (each Cycle is 21 Days)
Method of measurement
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
6
Description
Comparison of the Severity of Anorexia in Two Groups receiving Mirtazapine and Olanzapine
Timepoint
During the Acute Phase [0-24 Hours after Chemotherapy (CT)], the Delayed (24-120 Hours after CT) and the Overall (0-120 Hours after CT) Phases for Two CT Cycles (each Cycle is 21 Days
Method of measurement
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Intervention groups
1
Description
Intervention group 1: Eligible patients will receive: Triple Standard of Care Regimen [Aprepitant Capsule (125 mg PO OD on day 1, 80 mg OD on days 2-3), Granisetron (1 mg IV only on day 1), Dexametason (12 mg IV only on day 1)] and Mirtazapine Tablet (15 mg PO OD on days 1-4). The first Day of Chemotherapy begins Half an Hour to an Hour before Chemotherapy.
Category
Prevention
2
Description
Intervention group 2: Eligible Patients will receive Triple Standard of Care Regimen [Aprepitant Capsule (125 mg PO OD on Day 1, 80 mg OD on Days 2-3), Granisetron (1 mg IV only on Day 1), Dexametason (12 mg IV only on Day 1)] and Olanzapine Tablet (10mg PO OD on Days 1-4). The first Day of Chemotherapy begins Half an Hour to an Hour before Chemotherapy. In Patients at Risk of Sedation, the Dose of Olanzapine is considered to be 5 mg.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Medical Oncology, Ayatollah Taleghani hospital
Full name of responsible person
Mojtaba Ghadiany
Street address
Department of Medical Oncology, Taleghani hospital, Erabi St, Shahid Chamran Highway,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
Ghadianymojtaba@yahoo.com
Web page address
Https://taleghani.sbmu.ac.ir/
2
Recruitment center
Name of recruitment center
Department of Medical Oncology, Baghiyyatollah al-Azam hospital
Full name of responsible person
Mojtaba Ghadiany
Street address
Department of Medical Oncology, Baghiyyatollah al-Azam hospital, Mollasadra St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8216 2444
Fax
Email
Ghadianymojtaba@yahoo.com
Web page address
Https://baq.bmsu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Erabi St, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Web page address
Https://sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli-Ardakani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Shahid Beheshti School of Pharmacy, Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0085
Email
Mariatavakoli@sbmu.ac.ir
Web page address
Https://pharmacy.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli-Ardakani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti School of Pharmacy, Niayesh Highway,Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0085
Email
Mariatavakoli@sbmu.ac.ir
Web page address
Https://pharmacy.sbmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alimohammad Maleki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Clinical pharmacy
Street address
Shahid Beheshti School of Pharmacy, Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 2261 3871
Email
Drpharmacist58@yahoo.com
Web page address
Https://pharmacy.sbmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD