Comparison of the effect of prophylactic granulocyte colony-stimulating factor versus placebo on neutrophil count before chemotherapy on children with malignant neuroblastoma
Background and Objectives: the aim of this study is the valuation of prophylactic granulocyte colony-stimulating factor before chemotherapy on children's with malignant neuroblastoma; Major inclusion and exclusion criteria: patients with pathologically confirmed neuroblastoma, stage 3 and 4 of disease, normal cell counts before each cycle of chemotherapy, absolute neutrophil count above 1000 and platelet count above 100000 per cubic microliter will be enrolled into the study and patients with previous history of receiving granulocyte colony stimulating factor will be excluded from the study. Study population and size; a number of 50 children with malignant neuroblastoma will randomly be assigned into two equal intervention and control groups. Interventions and major outcomes: we use granulocyte stimulating factor for intervention group three times prior to the chemotherapy for the intervention group and three times of placebo three times prior to the chemotherapy for the control group, the major final outcome is the increased neutrophil count in complete blood count after three days of chemotherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050717610N1
Registration date:2014-09-27, 1393/07/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-27, 1393/07/05
Registrant information
Name
Azim Rezamand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 2299
Email address
rezamand@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of prophylactic granulocyte colony-stimulating factor versus placebo on neutrophil count before chemotherapy on children with malignant neuroblastoma
Public title
Evaluation of prophylactic granulocyte colony-stimulating factor before chemotherapy on children's with malignant neuroblastoma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: pathologically confirmed neuroblastoma; age below 16 years; stage 3 and 4 of disease; normal cell counts before each cycle of chemotherapy; absolute neutrophil count above 1000 and platelet count above 100000 per cubic microliter
Exclusion Criteria: previous history of receiving granulocyte colony stimulating factor
Age
From 6 months old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tabriz University of Medical Sciences
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht avenue, Azadi street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2014-02-12, 1392/11/23
Ethics committee reference number
5/4/10440
Health conditions studied
1
Description of health condition studied
malignant noroblastoma
ICD-10 code
C74.9
ICD-10 code description
Adrenal gland, unspecified
Primary outcomes
1
Description
Increased numbers of neutrophils
Timepoint
3 days
Method of measurement
Complete blood count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: granulocyte colony stimulating factor three times prior to chemotherapy and one time after the chemotherapy
Category
Treatment - Drugs
2
Description
Control group: placebo, three times prior to chemotherapy and one time after the chemotherapy