Efficacy of Allium extract administration in increasing peripheral blood neutrophil count in pediatric cancer patients admitted due to febrile neutropenia
We are going to determine if allium extract can speed up bone marrow recovery of cancer patients who are admitted post chemotherapy with febrile neutropenia.
100 patients are equally divided to two groups. Group1 will take filgrastim as well as Allium extract capsule. The other group will take filgrastim and placebo. CBC will be checked daily and the time to bone marrow recovery will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051615666N2
Registration date:2015-05-31, 1394/03/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-05-31, 1394/03/10
Registrant information
Name
Mohammad Reza Bordbar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 3239
Email address
bordbarm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-06-01, 1394/03/11
Expected recruitment end date
2016-06-01, 1395/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Allium extract administration in increasing peripheral blood neutrophil count in pediatric cancer patients admitted due to febrile neutropenia
Public title
Efficacy of leek vegetable in augmenting the immune system of children with cancer admitted due to fever and infection
Purpose
Treatment
Inclusion/Exclusion criteria
All children in the age range of 4-18 years who suffer from any kind of cancer and admitted post chemotherapy with febrile neutropenia are included.
Those with known history of severe hypersensitivity reaction to the leek vegetable or other family members of garlic are excluded.
Age
From 4 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz university of Medical Sciences
Street address
Zand street- main building of Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2015-03-06, 1393/12/15
Ethics committee reference number
CT-P-9371-7331
Health conditions studied
1
Description of health condition studied
Post chemotherapy neutropenia in cancer patients
ICD-10 code
D70
ICD-10 code description
Agranulocytosis
Primary outcomes
1
Description
Absolute neutrophil count
Timepoint
daily
Method of measurement
CBC, diffrential
Secondary outcomes
1
Description
hospital stay
Timepoint
at the time of discharge from hospital
Method of measurement
calculation
Intervention groups
1
Description
Group 1: will take subcutaneous/Iv injection of filgrastim 5 microgram/kg daily as well as Allium extract capsule twice daily containing equal to 1200 miligram allium powder. The capsules will be continued for 7 days unless abolute neutrophile count rises to more than 500 which will be withheld sooner.
Category
Treatment - Drugs
2
Description
Group 2 (control):50 patients are included in this group. They will be treated with filgrastim 5microgram/kg sc/IV injection daily the same as group1. However, instead of Allium capsule they will be given placebo capules twice daily for 7 days unless ANC comes to above 500 which will be discontinued earlier.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Oncology Hospital
Full name of responsible person
Street address
14th station- Farhangshahr street- Amir Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of research of Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Zand street- main building of Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of research of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
medical school
Full name of responsible person
mohammadreza bordbar
Position
pediatric hematologist
Other areas of specialty/work
Street address
Farhangshahr- Amir Oncology Hospital
City
Shiraz
Postal code
Phone
+98 71 3632 3532
Fax
Email
bordbarm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
medical school
Full name of responsible person
mohammadreza bordbar
Position
pediatric hematologist
Other areas of specialty/work
Street address
Farhangshahr- Amir Oncology Hospital
City
Shiraz
Postal code
Phone
+98 71 3632 3532
Fax
Email
bordbarm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
medical school
Full name of responsible person
mohammadreza bordbar
Position
pediatric hematologist
Other areas of specialty/work
Street address
Farhangshahr- Amir Oncology Hospital
City
Shiraz
Postal code
Phone
+98 71 3632 3532
Fax
Email
bordbarm@sums.ac.irt
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)