A Non-randomized, Single-armed Clinical trial study to determine the therapeutic efficacy of Pegfilgrastim (CinnaGen Company) to treatment of anemia consequent taxans chemotherapy in breast cancer patients
The primary objective of this study was evaluation of efficacy and safety of Pegfilgrastim (PegaGen®, CinnaGen Co.) in treatment of hematological adverse events due to the administration of taxane-based chemotherapy in breast cancer patients. The intended population included breast cancer woman patients aged less than 65 and with cancer stages I-III. Patients with metastatic disease, hepatic impairment, myelosuppression, pregnancy or breastfeeding were excluded from the trial. All of patients received the standard chemotherapy regimen according to treatment protocol of breast cancer institute, consisting of 4 cycles of Adriamycin plus cyclophosphamide followed by 4 cycles of Taxotere. A 6-mg single dose injection of Pegfilgrastim was administered in the beginning of each cycle to improve the hematological profile in patients. Hematological profile was assessed for all patients before each chemotherapy cycle. The main objective was the frequency of neutropenia of less than 1000 per micro-liter in patient CBC test. In addition, the frequency of bone pain, injection site pain, injection site reactions, thrombocytopenia, fever and hospitalization were evaluated. All patients were followed and assessed from the time of randomization until 2 weeks after the last chemotherapy cycle.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012121315N7
Registration date:2017-03-12, 1395/12/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-12, 1395/12/22
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
Recruitment complete
Funding source
CinnaGen Company
Expected recruitment start date
2012-08-09, 1391/05/19
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Non-randomized, Single-armed Clinical trial study to determine the therapeutic efficacy of Pegfilgrastim (CinnaGen Company) to treatment of anemia consequent taxans chemotherapy in breast cancer patients
Public title
The effect of Pegfilgrastim on treatment of anemia consequent taxans chemotherapy in breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: breast cancer stage I-III and women between the age of 18-65 years at the time of signing the informed consent form.
Exclusion criteria: patients with metastatic breast cancer; liver failure or myelosuppression; pregnancy or lactation and dissatisfaction.
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Research Institute
Street address
Avicenna Research Institute, Inside Shahihid Beheshti University of Medical Sciences, Velenjak), Street Yemen, Street Din Fadl Allah, the martyr Beheshti University
City
Tehran
Postal code
1177-19615
Approval date
2012-05-22, 1391/03/02
Ethics committee reference number
91/ص/15/881
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site
2
Description of health condition studied
Neutropenia
ICD-10 code
D70
ICD-10 code description
Neutropenia
Primary outcomes
1
Description
pegfilgrastim efficacy at grade 3 and 4 neutropenia from second cycle at chemotherapy regimen include taxans at breast cancer
Timepoint
Every two weeks until two weeks after the last dose of pegfilgrastim
Method of measurement
Cell Blood Count (CBC)
Secondary outcomes
1
Description
Determining the frequency of grade 3 and 4 neutropenia
Timepoint
Every two weeks until two weeks after the last dose of pegfilgrastim
Method of measurement
Cell Blood Count (CBC)
2
Description
Determining the frequency of bone pain
Timepoint
Every two weeks until two weeks after the last dose of pegfilgrastim
Method of measurement
patient assessment
3
Description
Determining the frequency of injection site pain
Timepoint
Every two weeks until two weeks after the last dose of pegfilgrastim
Method of measurement
patient assessment
4
Description
Determining the frequency of injection site reaction
Timepoint
Every two weeks until two weeks after the last dose of pegfilgrastim
Method of measurement
Physician assessment
5
Description
Determining the frequency of thrombocytopenia
Timepoint
Every two weeks until two weeks after the last dose of pegfilgrastim
Method of measurement
CBC (Cell Blood Count)
6
Description
Determining the frequency of febrile neutropenia
Timepoint
Every two weeks until two weeks after the last dose of pegfilgrastim
Method of measurement
Physician assessment
7
Description
Determining the frequency of hospitalization
Timepoint
Every two weeks until two weeks after the last dose of pegfilgrastim
Method of measurement
Physician assessment
Intervention groups
1
Description
CinnaGen Pegfilgrastim (Prefilled syringe: 6 mg / 0.6 ml for SC Injection,Single Dose Every Two Weeks for 24 months)