The purpose of this study was to determine the effect of olanzapine on the prevention of nausea and vomiting induced by radiotherapy in patients with abdominal cancer
Design
In this study, 60 eligible patients with abdominal cancer in the radiotherapy clinic 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
The study will be double-blind. The treating physician and the researcher will randomly place patients in the control and intervention groups. The control group will be prescribed the usual antiemetic treatment with a placebo. For the intervention group, in addition to the usual antiemetic drugs, olanzapine tablets at a dose of 5 mg for patients under 60 kg and olanzapine 10 mg tablets for patients over 60 kg, one day before the start of radiotherapy until the fifth day of treatment (6 days in total) Will. Patients and questioners will not know the type of groups.
The questionnaires will be completed one day before radiotherapy, on the first, third and fifth day or one day after radiotherapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Completing the consent form and announcing the cooperation, Age over 18 years old, Radiotherapy Cause of cancer (patients who undergo chemotherapy or surgery in addition to radiotherapy), Radiotherapy for the first time.
Exclusion criteria: Patients with proven diabetes, Patients taking anti-lipid drugs, Patients taking antipsychotic drugs, including olanzapine.
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
IRCT registration information
IRCT registration number:IRCT20170814035697N7
Registration date:2022-02-27, 1400/12/08
Registration timing:registered_while_recruiting
Last update:2022-02-27, 1400/12/08
Update count:0
Registration date
2022-02-27, 1400/12/08
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
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment of the effect of Olanzapine on the prevention of radiotherapy-induced nausea and vomiting in patients with abdominal cancers
Public title
The effect of Olanzapine on the prevention of radiotherapy-induced nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Complete the consent form and announce cooperation
Age over 18 years
Radiotherapy for cancer (patients undergoing chemotherapy or surgery in addition to radiotherapy)
Radiotherapy for the first time
Exclusion criteria:
Patients with proven diabetes
Patients taking anti-lipid drugs
Patients taking antipsychotic drugs, including olanzapine
Pregnant women
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
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
2021-12-01, 1400/09/10
Ethics committee reference number
IR.UMSU.REC.1400.374
Health conditions studied
1
Description of health condition studied
Radiotherapy 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 radiotherapy
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 radiotherapy until the fifth day of therapy (total 6 days)
Category
Treatment - Drugs
2
Description
Control group: Routine anti-vomiting treatment with placebo