This randomized double blind placebo controlled clinical trial will be conducted on 87 women with breast cancer, aged between 18-65 years , referring Kermanshah imam reza hospital and suffering from hot flash who volunteer for treatment. The patient will be randomly assigned in to 3 groups,2 intervention groups and one control group(n=29 each)In intervention groups patients, one group will take escitalopram 10 mg ,one time a day for 4 weeks and the other group will take relaxation methods ,once a day for 4 weeks. The control group will receive placebo tablet, one time a day for 4 weeks. The data collection will be done through interviews and a questionnaire considering demographic and hot flash diary. Then duration, severity and frequency of hot flashes will be assessed before treatment and 4 weeks after treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072834482N2
Registration date:2017-08-22, 1396/05/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-22, 1396/05/31
Registrant information
Name
Maryam Shirzadi
Name of organization / entity
Kermanshah University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 5255
Email address
m_shirzadi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of escitalopram ,placebo and relaxation on hot flashes of patients with breast cancer
Public title
Effect of of escitalopram and relaxation on hot flashes of patients with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having at least 4 hot flash attacks daily; Age range is 18 to 65 years; a history of breast cancer; not in acute phase of breast cancer, Ability to read and write and being able to answer questions ;Consent to participate in the study; Not concurrent using of any drugs that affect hot flash symptoms such as gabapentin, pregabalin, clonidine, SSRIs, herbal drugs and other treatments such as acupuncture, hypnotism ; no Non-malignant hypertension or CVA or MI or other uncontrolled organic problems and psychotic or bipolar disorders
Exclusion criteria: incidence of intolerable drug side effects, breast cancer relapse needing chemotherapy
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
87
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Number 2 Building ,Shahid Beheshti Boulevard
City
Kermanshah
Postal code
Approval date
2017-02-05, 1395/11/17
Ethics committee reference number
KUMS.REC.1396.2
Health conditions studied
1
Description of health condition studied
Hot Flash
ICD-10 code
N95.3
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
hotflash frequency
Timepoint
before treatment and 4 weeks after treatment
Method of measurement
Hotflash diary
Secondary outcomes
1
Description
hotflash duration
Timepoint
before treatment and 4 weeks after treatment
Method of measurement
Hotflash diary
Intervention groups
1
Description
Intervention group: Escitalopram tab 10mg one time a day for 4 weeks
Category
Treatment - Drugs
2
Description
control group:Placebo tab one time a day for 4 weeks
Category
Placebo
3
Description
Intervention group: relaxation methods at least 30 minutes one time a day for 4 weeks
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah Imam Reza Hospital
Full name of responsible person
Dr Maryam Shirzadi
Street address
Kermanshah Imam Reza Hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behrouz Hamzeh
Street address
Number 2 Building ,Shahid Beheshti Boulevard
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University Of Medical Science
Full name of responsible person
Dr Maryam Shirzadi
Position
Assisstant Professor Of Psychiatry
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 3427 6310
Fax
Email
m_shirzadi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University Of Medical Science
Full name of responsible person
Dr Maryam Shirzadi
Position
Psychiatrist
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 3427 6310
Fax
Email
m_shirzadi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University Of Medica Science
Full name of responsible person
Dr Maryam Shirzadi
Position
Psychiatrist
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 3427 6310
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)