Comparison of efficacy and adverse effects of filgrastim produced by Samen pharmaceutical company and neupogen as a standard drug in Breast Cancer Patients
The aim of this study is comparison of efficacy and advers effect of filgrastim produced by samen company and Neupogen as a standard drug in breast cancer patients.168 locally advance breast cancer patients without neutropenia , hepatic and renal failure will enter in the randomized parallel double blind clinical trial. Patients will be stratified into two groups based on chemotherapy regimen then patients in each group will be randomized into two groups who will receive filgrastim produced by Samen Company or neupogen . The dose of each drug is 5 microgram/kg and will be adminstrated 24 hours after chemotherapy for5 days. Finally efficacy and adverse effects of drugs in each group will be evaluated base on clinical , preclinical and laboratory findings. Frequency of neutropenia, duration of neutropenia and adverse effects will compare between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206279801N3
Registration date:2013-12-19, 1392/09/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-12-19, 1392/09/28
Registrant information
Name
Amir Hooshang Mohammadpour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
mohamadpoorah@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Samen Company
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and adverse effects of filgrastim produced by Samen pharmaceutical company and neupogen as a standard drug in Breast Cancer Patients
Public title
Comparison of filgrastim produced by Samen Pharmaceutical Company and Neupogen as a standard drug
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age>18 yr; Diagnosis of locally advanced breast cancer; WHO Performance Status less than or equal of 2; Absence of neutropenia (ANC <1500/mm3) before starting chemotherapy; Completing the Consent form.
Exclusion criteria: History of hypersensitivity reaction to biologic drugs; Existence of renal failure ; Existence of hepatic failure ; Coadministration of neutropoietic drugs; Existence of cardiac arrythmia.
Age
From 18 years old to 80 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
168
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ethic committee of Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah street
City
Mashhad
Postal code
91375-345
Approval date
2009-01-19, 1387/10/30
Ethics committee reference number
5/10492
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
duration of neutropenia
Timepoint
between day 1 to day 21 post chemotherapy
Method of measurement
laboratory
Secondary outcomes
1
Description
frequency of neutropenia episode
Timepoint
between day 1 to 21 post chemotherapy
Method of measurement
laboratory
Intervention groups
1
Description
Samen GCSF (5 microgram/kg for 5 days 1 day after chemotherapy)
Category
Treatment - Drugs
2
Description
NEUPOGEN ( 5 microgram/kg for 5 days , 1 day after chemotherapy)