Determine the role of vitamin B6 in the treatment of nausea and vomiting due to chemotherapy
Design
Triple blind clinical trials and In the first stage, they receive vitamin B6 and in the next stage receive placebo.
Settings and conduct
This study will be conducted as a triple blind clinical trial in children with malignancy undergoing chemotherapy in Amirkabir Hospital in Arak. A total of 100 patients undergoing chemotherapy due to malignancy are included in the study.
Blinding will performed by the head nurse of blood ward and takes the amount of vitamin B6 and distilled water and preserves, it as a medicine A = vitamin B6 and B = distilled water. The nurse and therapist do not know the type of drug.
In the sample, we examine how chemotherapy has been used in these two cycles to cure nausea and vomiting, as well as severity.
Participants/Inclusion and exclusion criteria
Children with malignancy who are undergoing chemotherapy and referred to Amirkabir Hospital in Arak
Intervention groups
Patients in one step of study 6 hours before chemotherapy receive vitamin B6 and in another step receive placebo with the same dose.
Main outcome variables
nausea and vomiting.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150119020715N8
Registration date:2018-07-22, 1397/04/31
Registration timing:retrospective
Last update:2018-07-22, 1397/04/31
Update count:0
Registration date
2018-07-22, 1397/04/31
Registrant information
Name
Aziz Eghbali
Name of organization / entity
دانشگاه علوم پزشکی اراک
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 5314
Email address
dr.eghbali@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
empty
Scientific title
The effect of intravenous Vitamin B6 administration in Prevention of chemotherapy induced nausea and vomiting in children with malignancy.
Public title
The effect of intravenous Vitamin B6 administration in Prevention of nausea and vomiting due to chemotherapy in pediatrics.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
desire to participate in the study
Children with malignancy who need to chemotherapy
2 to 15 years of age
Exclusion criteria:
Unwilling to participate in the study
patients with Immune deficiency
patients with cardiovascular disease
patients with AIDS
patients with renal failure
patients with diabetes
Age
From 2 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Clinical care will be blind of the type of medication.
Researchers are also blind of the grouping.
Data analyzer is also blind of the grouping.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
38481769411
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.ARAKMU.REC.1395.443
Health conditions studied
1
Description of health condition studied
nausea and vomiting
ICD-10 code
R11.2
ICD-10 code description
Nausea with vomiting, unspecified
Primary outcomes
1
Description
nausea and vomiting
Timepoint
The frequency of nausea and vomiting is recorded within 24 hours.
Method of measurement
Recorded in checklist.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In a cycle of chemotherapy for the patient, in addition to the use of Granisetron (3 mg / 3 ml), injected into the sample for a half-hour before the chemotherapy was given intravenously vitamin B6 (in the age group of 2-5 years 100 mg - 5-10 years 200 mg - over 10 years 300 mg) 6 hours before chemotherapy is given to an individual.
Category
Treatment - Drugs
2
Description
Control group: In the next cycle of chemotherapy, the same patient as the same previous chemotherapy drug, in addition to the Granisetron, was used as placebo in the same dose of distilled water, and the distilled water was injected intravenously 6 hours before chemotherapy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir Hospital
Full name of responsible person
Aziz Eghbali
Street address
Amir Kabir Hospital, Alamolhoda street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
dr.eghbali@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad arjomandzadegan
Street address
3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Aziz Eghbali
Position
Faculty, Pediatrics Oncologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amir Kabir Hospital, Alamalhoda street, Arak
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3313 4715
Fax
+98 86 3313 3193
Email
aziz_eghbali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Aziz Eghbali
Position
Faculty, Pediatrics Oncologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amir Kabir Hospital, Alamalhoda street, Arak
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3313 4715
Fax
+98 86 3313 3193
Email
aziz_eghbali@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Aziz Eghbali
Position
Faculty, Pediatrics Oncologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amir Kabir Hospital, Alamalhoda street, Arak
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3313 4715
Fax
+98 86 3313 3193
Email
aziz_eghbali@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants information will remain confidential
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available