Evaluation of the effect of Mirtazapine on improving the quality of life of the brest Cancer patients
Design
With the method of easy sampling of people referring to the chemotherapy and radiotherapy center who are eligible, after selecting the sample, they are randomly divided into two groups of intervention and control. Clinical trial with control group with parallel, double-blind and randomized groups is performed by permutation block method, phase 3 and on 110 patients.
Settings and conduct
Study place: Chemotherapy and radiotherapy center of Vasei hospital in Sabzevar;
Type of blinding: single blind;
How to blind: It is prescribed by the relevant therapist as a routine treatment for breast cancer
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Breast cancer; Not taking sleeping pills at the same time;
Major depressive disorders according to DSM IV criteria
Non-inclusion criteria:
Concomitant cancer other than breast cancer;
Taking other psychiatric medications before entering the study
Intervention groups
Intervention group (Mirtazapine): In this group, 55 patients are prescribed mirtazapine at a dose of 15-30 mg daily under the supervision of a psychiatrist based on the quality of life test score for 8 weeks.
Control group: There are 55 patients in this group and no additional therapeutic intervention and action is prescribed except for routine cancer treatment.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210425051075N1
Registration date:2021-10-15, 1400/07/23
Registration timing:registered_while_recruiting
Last update:2021-10-15, 1400/07/23
Update count:0
Registration date
2021-10-15, 1400/07/23
Registrant information
Name
Houman Kamranian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 1037
Email address
kamranianh@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-21, 1400/02/31
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Mirtazapine on the quality of life of the breast cancer patients
Public title
Effect of Mirtazapine on the quality of life of the breast cancer patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from cancer
Major depressive disorder according to DSM IV criteria
Exclusion criteria:
Taking sleeping pills at the same time
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
By easy sampling method, people who refer to the Chemotherapy and Radiotherapy Center who are eligible are randomly divided into two groups of intervention and control after selecting the sample. In this study, individuals were divided into two groups using permutation block method. In this method, A represents the individual receiving the intervention and B represents the individual in the control group. Considering the quadruple block; We give AABB code 0, ABAB code 1, ABBA code 2, BAAB code 3, BBAA code 4 and BABA code 5. Then, using a table of random numbers, we randomly selected the starting point. Considering the order of the numbers in the table, we place the permutation corresponding to each number we encounter. Therefore, by selecting the numbers from the table, the method of assigning a total of 110 people to the two groups will be determined
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants in the blind plan had no knowledge of any other treatment other than routine cancer treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences; Shohadaye-Hasteiy blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9414974877
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.MEDSAB.REC.1399.192
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
c50
ICD-10 code description
Malignant neoplasm of breast
2
Description of health condition studied
Major depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Quality of Life
Timepoint
Study first and 8 weeks after starting mirtazapine
Method of measurement
WHO Quality of Life Questionnaire
2
Description
Anxiety
Timepoint
Study first and 8 weeks after starting mirtazapine
Method of measurement
WHO Quality of Life Questionnaire
3
Description
Sleep status
Timepoint
Study first and 8 weeks after starting mirtazapine
Method of measurement
WHO Quality of Life Questionnaire
4
Description
Appetite status
Timepoint
Study first and 8 weeks after starting mirtazapine
Method of measurement
WHO Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will be treated with Mirtazapine 15-30 mg daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Continuation of routine therapeutic care and no additional therapeutic intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Chemotherapy and Radiotherapy Center in Vasei hospital
Full name of responsible person
Houman Kamranian
Street address
No.11, Motahhari 17 street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9414974877
Phone
+98 51 4465 1037
Email
drkamranian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences; Shohadaye-Hasteiy blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9414974877
Phone
+98 51 4401 1000
Email
info@medsab.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Danial Kamrani
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 48; Sayad-e-Shirazi blvd 21
City
Mashhad
Province
Razavi Khorasan
Postal code
9179986981
Phone
+98 51 3865 5892
Email
danialkamrani96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Houman Kamranian
Position
Assistante professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No.17, Motahhari 11 street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9414974877
Phone
+98 51 4465 1037
Email
drkamranian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Houman Kamranian
Position
Assistante professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No.17, 11Motahhari st.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9414974877
Phone
+98 51 4465 1037
Fax
Email
kamranianh@medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after making people unidentifiable
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Can be used by all researchers
Under which criteria data/document could be used
There are no restrictions for other researchers
From where data/document is obtainable
Daniel Kamrani
Email danialkamrani96@gmail.com
Mobile 05138655892
Address: Sayad Shirazi St., No. 21
What processes are involved for a request to access data/document
The applicant will send his / her application by email to the relevant researcher by mentioning the title of his / her research and the necessary information will be sent to him / her within a maximum period of 1 month.