Evaluation of intravenous Vitamin B6 administration on chemotherapy induced
nausea and vomiting in children suffering from malignancy
Design
This study will be conducted as a triple-blind clinical trials in children with malignancy undergoing chemotherapy in Amir Kabir Hospital in Arak.
A total of 100 patients undergoing chemotherapy due to malignancy are included in the study.
Settings and conduct
This study will be conducted as a triple-blind clinical trials in children with malignancy undergoing chemotherapy in Amir Kabir Hospital in Arak.
Participants/Inclusion and exclusion criteria
Inclusion criteria: over 2 years old; both gender; children with malignancy
Exclusion criteria: Dissatisfaction to participate in the study
Intervention groups
Intervention group: In intervention group, patients are provided by Granisteron, 3 milligram in 3 milliliter, intravenously, 30 minutes before chemotherapy and vitamin B6 100 mg in 2-5 year age group, 200 mg in 5-10 year age group and 300 mg in over 10 year age group, intravenously, 6 hours before chemotherapy. In next chemotherapy cycle in same patients, they are provided by Granisteron, 3 milligram in 3 milliliter, intravenously, 30 minutes before chemotherapy and normal saline every 6 hours before chemotherapy.
Main outcome variables
Nausea; vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N67
Registration date:2018-02-16, 1396/11/27
Registration timing:registered_while_recruiting
Last update:2018-02-16, 1396/11/27
Update count:0
Registration date
2018-02-16, 1396/11/27
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-10, 1395/12/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intravenous Vitamin B6 administration in chemotherapy induced nausea and vomiting in children suffering from malignancy
Public title
Effect of intravenous Vitamin B6 administration in chemotherapy induced nausea and vomiting
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
being at the age of 2 to 5 years
both gender
Children with malignancy
Exclusion criteria:
Dissatisfaction to participate in the study
Age
From 2 years old to 5 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant and Analyzer are blind.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University Of Medical Sciences
Extravasation of vesicant antineoplastic chemotherapy
Primary outcomes
1
Description
Nausa
Timepoint
From beginning to the end of the chemotherapy session
Method of measurement
questionnaire
2
Description
vomitting
Timepoint
From beginning to the end of the chemotherapy session
Method of measurement
questionnaire
3
Description
Severity of nausea and vomiting
Timepoint
From beginning to the end of the chemotherapy session
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group, patients are provided by Granisteron, 3 milligram in 3 milliliter, intravenously, 30 minutes before chemotherapy and vitamin B6 100 mg in 2-5 year age group, 200 mg in 5-10 year age group and 300 mg in over 10 year age group, intravenously, 6 hours before chemotherapy. In next chemotherapy cycle in same patients, they are provided by Granisteron, 3 milligram in 3 milliliter, intravenously, 30 minutes before chemotherapy and normal saline every 6 hours before chemotherapy.