Investigating the role of olanzapine in reducing nausea and vomiting caused by chemotherapy in patients undergoing chemotherapy
Design
This double-blind randomized clinical trial study with parallel groups will be conducted on 42 patients undergoing chemotherapy with confirmed malignancy in Jahrom city. Patients participating in the study will be divided into two groups using a table of random numbers.
Settings and conduct
Patients referred to Jahrom Cancer Clinic who will undergo chemotherapy will be included in the study. Patients participating in the study will be divided into two groups using a random number table. The person participating in the study, the researcher and the person collecting the data will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People undergoing chemotherapy in Jahrom city with confirmed malignancy who have consented to participate in the study. Non-entry conditions: It includes patients who are hypersensitive to olanzapine and suffer from cognitive diseases and neurological diseases.
Intervention groups
Intervention group 1: They will receive a standard anti-nausea regimen including: 8 mg of intravenous dexamethasone, along with 1 mg of granistrone and aperitnet 125 minutes before chemotherapy on the first day. Also, in the standard regimen, Apritent 80 will be continued on the second and third day, and they will receive 5 mg of olanzapine every morning for 5 days. Intervention group 2: As a control group, the entire protocol of the intervention group is exactly repeated, except that instead of olanzapine, a placebo of the same form as olanzapine tablets containing starch and flour will be used.
Main outcome variables
Complete response to treatment as defined by the absence of nausea and vomiting or the need to receive adjuvant medication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050976N14
Registration date:2024-02-19, 1402/11/30
Registration timing:retrospective
Last update:2024-02-19, 1402/11/30
Update count:0
Registration date
2024-02-19, 1402/11/30
Registrant information
Name
navid kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
k.navid@juma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the role of Elanzapine in reducing nausea and vomiting caused by chemotherapy in patients undergoing chemotherapy
Public title
Investigating the role of Elanzapine in reducing nausea and vomiting caused by chemotherapy in patients undergoing chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age with pathologically or cytologically confirmed malignancy
Patients undergoing emtogenic chemotherapy including carboplatin, irinotecan, cyclophosphamide
Serum creatinine ≤2.0 mg/dl.
Written informed consent
Exclusion criteria:
being pregnant
Suffering from cognitive diseases and neurological diseases
Treatment with another psychiatric medication such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone within 30 days before or during protocol treatment
Simultaneous abdominal radiotherapy
Simultaneous use of quinolone antibiotic treatment
Chronic alcoholism
Hypersensitivity to olanzapine
Known heart disease
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Generation of random numbers from the table of random numbers: Considering that 42 patients are needed in this study, one number is randomly selected in the table of random numbers and the two digits to the right of it are taken into account, if these two digits are an even number, the patient is assigned to the group intervention, and if there is an individual, he will be assigned to the control group. For example, in the table of random numbers, the number 13 was chosen because 13 is an odd number, so the first sample will be assigned to the control group. In the table, random numbers move in rows from left to right, and with the above pattern, the method of assigning people to two groups is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in the present study, a double-blind method is used so that 1- the person who checks the results and 2- the person who prescribes the drugs do not know which patient received olanzapine. Blinding of the researcher and the patient will be done by placing the drug in similar packages without information about the type of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Motahari Street, Jahrom University of Medical Sciences
City
Jahram
Province
Fars
Postal code
7167758256
Approval date
2023-10-29, 1402/08/07
Ethics committee reference number
IR.JUMS.REC.1402.083
Health conditions studied
1
Description of health condition studied
Nausea and vomiting caused by chemotherapy
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Complete response to treatment as defined by the absence of nausea and vomiting or the need to receive adjuvant medication
Timepoint
Starting on the first day of treatment with olanzapine (day-2) and daily until day 5
Method of measurement
Using the Visual Analogue Scale
Secondary outcomes
1
Description
Duration of nausea
Timepoint
Starting on the first day of treatment with olanzapine (day-2) and daily until day 5
Method of measurement
According to the length of time the person has been nauseous
2
Description
Number of vomiting
Timepoint
Starting on the first day of treatment with olanzapine (day-2) and daily until day 5
Method of measurement
According to the number of times the person has vomited
Intervention groups
1
Description
Intervention group 1: They will receive a standard anti-nausea regimen including: 8 mg of intravenous dexamethasone, along with 1 mg of granistrone and aperitnet 125 minutes before chemotherapy on the first day. Also, in the standard regimen, Apritent 80 will be continued on the second and third day, and they will receive 5 mg of olanzapine every morning for 5 days.
Category
Treatment - Drugs
2
Description
Control group: The entire protocol of the intervention group is exactly repeated, except that instead of olanzapine, a placebo of the same form as olanzapine tablets containing starch and flour will be used.