The purpose of this study was to determine the effect of olanzapine on the prevention of nausea and vomiting induced by chemotherapy in cancer patients.
Design
In this study, 150 eligible patients with cancer admitted in the hematology and oncology ward of Imam Khomeini Hospital of Urmia are chosen. Patients will be randomly assigned into two groups of control and intervention, each patient will have a special code
Settings and conduct
This double-blind study aimed to determine the effect of Olanzapine on the prevention of nausea and vomiting in cancer patients admitted to the hematology and oncology ward of Urmia Imam Khomeini Hospital.
Patients were randomly assigned to the intervention and control groups. For the control group, routine anti-vomiting treatment with placebo and for the intervention group in addition to the routine anti-vomiting drugs, Olanzapine tablets will be prescribed. The daily dose of Olanzapine will be for patients with weight less than 60 kg and more than 60 kg; 5 mg and 10 mg, respectively. patients will be received the tablets one day before the start of chemotherapy until the fifth day (for a total of 6 days) for three periods of chemotherapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with over than 18 years; patients with cancer who are undergoing chemotherapy for the first time.
Exclusion criteria: having the allergy to olanzapine; patients with radiography and operated; diabetic patients; hyperlipidemia
Intervention groups
The study will be conducted with the participation of two groups of patients with cancer. The intervention group, which will receive the common anti-vomiting treatment with olanzapine and the control group, will receive a common anti-vomiting treatment with placebo.
Main outcome variables
nausea and vomiting
General information
Reason for update
Acronym
chemotherapy induced nausea and vomiting(CINV)
IRCT registration information
IRCT registration number:IRCT20170814035697N3
Registration date:2018-03-16, 1396/12/25
Registration timing:registered_while_recruiting
Last update:2018-03-16, 1396/12/25
Update count:0
Registration date
2018-03-16, 1396/12/25
Registrant information
Name
Hamdolah Sharifi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4992
Email address
sharifi.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Olanzapine on chemotherapy induced nausea and vomiting in patients with cancer : A randomized clinical trial
Public title
"The effect of Olanzapine on chemotherapy induced nausea and vomiting"
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old.
Chemotherapy due to cancer for the first time
Exclusion criteria:
Having allergic to olanzapine
Patients under Radiotherapy
Patients with surgical history
Diabetic patients
hyperlipidemia
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software, patients will be randomized into an intervention or a placebo groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and patients are blind in this study. The investigator and the patients will be unaware of the patients belong to intervention or placebo groups.
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences; Resalat Ave; Jahad Blvd; Urmia; West Azerbijan Provine; Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
Ir.umsu.rec.1396.131
Health conditions studied
1
Description of health condition studied
Chemotherapy induced nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
The nausea and vomiting severity
Timepoint
The before, first, third and fifth days of chemotherapy
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: routine treatment + olanzapine tablets with a dose of 5 mg for patients less than 60 kg and 10 mg for patients over 60 kg one day before the start of chemotherapy until the fifth day of therapy (total 6 days)
Category
Treatment - Drugs
2
Description
Control group: Routine anti-vomiting treatment with placebo