Clinical trial of comparison between prophylactic effect of filgrastim and pegfilgrastim on neutropenia caused by chemotherapy of solid tumors in children
The aim of this study is to compare the effect of Filgrastim and Pegfilgrastim in preventing chemotherapy induced neutropenia in children with solid tumors. Crossover study carried out in children who were admitted in oncology ward of Amirkabir Hospital. Inclusion criteria will be solid tumor confirmed by pathology, children less than 15 years and their parental consent. Exclusion criteria will be severe infection, Use of Corticosteroid, sensitivity to Filgrastim or Pegfilgrastim and lack of parental consent to continue participating in the study. Patients will be randomly divided into 3 groups of 30 and each group will be treated 24 hours after chemotherapy. The Filgrastim and Pegfilgrastim will injected subcutaneously with a 10 µg/kg/day dose and a 100 µg/kg as a single dose, respectively. Group one will be treated with a daily dose of Filgrastim in the first period and Pegfilgrastim in the second, separated by a washout period of at least 30 days. In contrast, the second group will be treated with a daily dose of Pegfilgrastim in the first period and Filgrastim in the other and the third group will be received no medication. Cell blood counts will be taken in the beginning and in the 3, 7, 14 days of the treatment. The side effects and duration of neutropenia and hospitalization due to adverse drug reactions as well as the delay in starting the next cycle of chemotherapy and chemotherapy dose reductions due to neutropenia and treatment costs will be recorded. Finally, collected data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011131878N1
Registration date:2017-04-29, 1396/02/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-29, 1396/02/09
Registrant information
Name
Maryam Behtash
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 936 620 8067
Email address
maryam.behtash@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-05-04, 1396/02/14
Expected recruitment end date
2017-10-06, 1396/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison between prophylactic effect of filgrastim and pegfilgrastim on neutropenia caused by chemotherapy of solid tumors in children
Public title
The comparison of effects of two drugs in neutropenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Solid tumor confirmed by pathology; Children less than 15 years; Parental consent.
Exclusion criteria: Severe infection; Use of Corticosteroid; Sensitivity to filgrastim or pegfilgrastim; Lack of parental consent to continue participating in the study.
Age
From 1 year old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Patients will be placed randomly in three groups using random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Arak University of Medical Sciences
Before chemotherapy and the first, third, seventh and fourteenth day after Granulocyte Colony Stimulating Factor (GCSF) administration.
Method of measurement
Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Group one will be treated with a daily dose of Filgrastim in the first period and Pegfilgrastim in the second, separated by a washout period of at least 30 days. The Filgrastim and Pegfilgrastim will injected subcutaneously with a 10 µg/kg/day dose and a 100 µg/kg as a single dose, respectively.
Category
Treatment - Drugs
2
Description
Intervention group 2: Group two will be treated with a daily dose of Pegfilgrastim in the first period and Filgrastim in the second, separated by a washout period of at least 30 days. The Filgrastim and Pegfilgrastim will injected subcutaneously with a 10 µg/kg/day dose and a 100 µg/kg as a single dose, respectively.
Category
Treatment - Drugs
3
Description
Control group: Third group will be received no medication.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Kabir Hospital
Full name of responsible person
Dr Aziz Eghbali
Street address
Amir-Kabir Hospital, Rah-Ahan Street, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences