comparison of the effect of melatonin and zolpidem in improving quality of sleep, anxiety and depression in colorectal cancer patients receiving chemotherapy
This study is a randomized, double blind clinical trial that will be done on 90 colorectal cancer patients who have sleep disorder based on Pittsburgh Sleep Quality Questionnaire and are receiving chemotherapy regimen. After obtaining ethical approval and written informed consent form the patients, the two groups will be selected based on simple random blocks. Group A will receive melatonin 6 mg at night and the other group receives 10 mg zolpidem. In this double-blind trial, neither the participants nor the researchers know which participants belong to the melatonin group, nor the zolpidem group. To assess sleep quality of patients, Pittsburgh Sleep Quality Criteria at baseline and after 4 and 8 weeks of treatment will be used, Groningen Sleep Quality Scale Questionnaire will be used at baseline and after 2, 4 and 8 weeks of treatment. To provide an indication of depression and anxiety, and as a guide to evaluate recovery, the Hamilton Rating Scale for Depression and Anxiety will be used at baseline and after 2, 4 and 8 weeks of treatment. Questionnaires will be completed under the supervision of a specialist in clinical psychology and the data extraction and analysis performed by a statistician.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602147202N10
Registration date:2017-09-10, 1396/06/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-10, 1396/06/19
Registrant information
Name
Padideh Ghaeli
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
pghaeli@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of medical science
Expected recruitment start date
2017-03-18, 1395/12/28
Expected recruitment end date
2017-08-19, 1396/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of melatonin and zolpidem in improving quality of sleep, anxiety and depression in colorectal cancer patients receiving chemotherapy
Public title
Comparison Between Melatonin and Zolpidem in Improving Sleep quality, Anxiety and Depression
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
age more than 18
colorectal cancer receiving chemotherapy regimen
sleep disorder based on pitsburg questionnaire
exclusion criteria:
patients receiving hypnotics, antidepressants or anxiolytic medicines
pregnancy
lactation
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of medical Science
Street address
16 Azar street, Enghelab square
City
Tehran
Postal code
Approval date
2017-03-11, 1395/12/21
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1911
Health conditions studied
1
Description of health condition studied
sleep disorder
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
Primary outcomes
1
Description
sleep quality
Timepoint
At baseline, 1 month after the baseline and 2 months after baseline
Method of measurement
Pittsburgh Questionnaire
2
Description
sleep quality
Timepoint
At baseline, 2 weeks and 1 month after the baseline and 2 months after baseline
Method of measurement
GSQS Questionnaire
Secondary outcomes
1
Description
depression
Timepoint
At baseline, 2 weeks and 1 month after the baseline and 2 months after baseline
Method of measurement
Hamilton Rating Scale for Depression
Intervention groups
1
Description
intervention:
6 mg melatonin every night for 30 days
Category
Treatment - Drugs
2
Description
control:
10 mg zolpidem at night for 30 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology ward, Sina hospital
Full name of responsible person
Ms. Ozlati
Street address
Hasan Abad squre
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Padideh Ghaeli
Street address
Tehran University of Medical Sciences, 16 Azar street, Enghelab square
City
Tehran
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, Tehran 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
tehran university of science
Full name of responsible person
dr. Padideh Ghaeli
Position
Professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Tehran University of Medical Sciences, 1 Azar St, Enqelab square
City
tehran
Postal code
Phone
+98 912 143 0668
Fax
Email
pghaeli@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
tehran university of medical science
Full name of responsible person
dr. mohsen sfandbod
Position
professor assistance
Other areas of specialty/work
Street address
oncology hematology ward, sina hospital, hasan abad squre
City
tehran
Postal code
Phone
+98 912 113 7334
Fax
Email
sfandbod@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
tehran university of medical cience
Full name of responsible person
dr maryam shahrokhi
Position
resident
Other areas of specialty/work
Street address
Faculty of Pharmacy, Tehran University of Medical Sciences, 1 Azar St, Enqelab square
City
tehran
Postal code
Phone
+98 913 348 4761
Fax
Email
shahrokhi.mail85@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)