Compare the effect of ondansetron and Dexamethasone with metoclopramide and Dexamethasone in the control of nausea and vomiting after chemotherapy in cancer patients referred to Imam Hossein hospitals of Shahroud on 2017, a randomized double blind clinical trial
Compare the effect of ondansetron and Dexamethasone with metoclopramide and Dexamethasone in the control of nausea and vomiting after chemotherapy
Design
In this study, 86 patients who are referred to Imam Hossein Shahroud Hospital are referred for chemotherapy and admission to study. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
This study was performed as a randomized clinical trial on patients referring to chemotherapy in Imam Hossein Hospital.The study is a double blind clinical trial in which the participants, the main researcher, the data collection authorities and those who evaluate the outcome are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
A definitive diagnosis of a cancer that needs chemotherapy
There is no other systemic disease (such as obstructive bowel disease and gastroenteritis, central nervous system problems, and equilibrium problems)
Have a previous history of chemotherapy at least three times
Age range 15 to 65 years
Fear and complain about severe and fairly intense nausea and vomiting in previous chemotherapy
No use oral antinausea or injection medicines in the last 7 days
Desire and satisfaction to enter the study
Exclusion criteria:
Use an anti-nausea and vomiting medicine for at least the past 7 days
Dissatisfaction with this treatment
Those who use drugs
There is a severe allergic reaction to either of the two drugs, Endonestrone and Metoclopramide
Dissatisfaction with cooperation and participation in the project
Intervention groups
Intervention group: Ondonestrone 0 / 1mg / kg with 2 cc normal saline plus 8 mg dexamethasone intravenously
Control group: Metoclopramide 0.15 mg / kg plus 8 mg dexamethasone intravenously
Main outcome variables
Severity of pain; nausea and vomiting; complication after treatment of two drugs; severe nausea after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170902036032N1
Registration date:2018-02-25, 1396/12/06
Registration timing:registered_while_recruiting
Last update:2018-02-25, 1396/12/06
Update count:0
Registration date
2018-02-25, 1396/12/06
Registrant information
Name
mehrshad mousapour
Name of organization / entity
medical student in shahroud medical sience university
Country
Iran (Islamic Republic of)
Phone
+98 990 173 6066
Email address
mousapour@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of ondansetron and Dexamethasone with metoclopramide and Dexamethasone in the control of nausea and vomiting after chemotherapy in cancer patients referred to Imam Hossein hospitals of Shahroud on 2017, a randomized double blind clinical trial
Public title
Compare the effect of ondansetron and Dexamethasone with metoclopramide and Dexamethasone in the control of nausea and vomiting after chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A definitive diagnosis of a cancer that needs chemotherapy
There is no other systemic disease (such as obstructive bowel disease and gastroenteritis, central nervous system problems, and equilibrium problems)
Have a previous history of chemotherapy at least three times
Age range 15 to 65 years
Fear and complain about severe and fairly intense nausea and vomiting in previous chemotherapy
No use oral antinausea or injection medicines in the last 7 days
Desire and satisfaction to enter the study
Exclusion criteria:
Use an anti-nausea and vomiting medicine for at least the past 7 days
Dissatisfaction with this treatment
Those who use drugs
There is a severe allergic reaction to either of the two drugs, Endonestrone and Metoclopramide
Dissatisfaction with cooperation and participation in the project
Age
From 15 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple, Individual randomization unit Using random quadrants blocks
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double blind clinical trial in which the participants, the main researcher, the data collection authorities and those who evaluate the outcome
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
shahroud University of Medical Sciences and Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.SHMU.REC.1395.124
Health conditions studied
1
Description of health condition studied
Under chemotherapy
ICD-10 code
Z51.11
ICD-10 code description
Encounter for antineoplastic chemotherapy
Primary outcomes
1
Description
Severity of pain
Timepoint
After treatment
Method of measurement
Visual Scale
2
Description
nausea and vomiting
Timepoint
After treatment
Method of measurement
Visual Scale
3
Description
complication after treatment of two drugs
Timepoint
After treatment
Method of measurement
Visual Scale
4
Description
severe nausea after treatment
Timepoint
After treatment
Method of measurement
Visual Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ondonestrone 0 / 1mg / kg with 2 cc normal saline plus 8 mg dexamethasone intravenously
Category
Treatment - Drugs
2
Description
Control group: Metoclopramide 0.15 mg / kg plus 8 mg dexamethasone intravenously
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Shahrood Hospital Medical Center
Full name of responsible person
Mehrshad Mousapour
Street address
Lane 28-meter Ayatollah Tohidi ,Imam Street. Shahrood City
City
Shahrood
Province
Semnan
Postal code
1448813879
Phone
+98 21 7792 6610
Email
mehrshadmousapour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Shahroud University of Medical Sciences and Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mehrshad Mousapour
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahroud University of Medical Sciences and Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Province
Semnan
Postal code
1648813879
Phone
+98 21 7792 6610
Email
mousapour@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mehrshad Mousapour
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahroud University of Medical Sciences and Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Province
Semnan
Postal code
1648813879
Phone
+98 21 7792 6610
Email
mousapour@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
mehrshad mousapour
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
shahroud University of Medical Sciences and Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Province
Semnan
Postal code
1648813879
Phone
+98 21 7792 6610
Email
mousapour@shmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available