24 women with newly diagnosed breast cancer underwent the dose dense chemotherapy regimen consisting of Taxoter, Cyclophosphamide and Adriamycine. The patients were assigned to two groups randomly. The first group was given single dose of 6 mg pegagen after the completion of the first course of chemotherapy, and the second course of chemotherapy was followed by daily subcutaneous injection of 300 ugr G-csf for 5 days. The second group was treated with G-csf after the first course of chemotherapy and was given pegagen following the second course.
white blood cell,Hb, neutrophil and drugs side effects were compared in these patients before, one week and 2 weeks after the chemotherapy
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020732444N1
Registration date:2017-03-30, 1396/01/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-30, 1396/01/10
Registrant information
Name
Mehrzad Salmasi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3263 0366
Email address
m.salmasi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-09-28, 1394/07/06
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Pegagen and G-csf in the chemotherapy induced cytopennia in the breast cancer patients
Public title
Comparison of the effects of Pegagen and G-csf in the treatment of cytopenia induced by breast cancer chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age >18 years old; absolute neutrophil count ≥1.5 × 109/l; platelet count ≥100 × 109/l; serum creatinine <1.5 × upper limit of normal.
Exclusion criteria: hypersinsitivity reaction; unwillingness of patients to continue; change of chemotherapy regimen.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
cross over clinical trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Postal code
8158177356
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
IR.MUI.REC.1395.3.546
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
neutrophil count
Timepoint
before chemothrapy and 1 weeks and 2 weeks later
Method of measurement
laboratory CBC
2
Description
Hb level
Timepoint
before chemothrapy and 1 weeks and 2 weeks later
Method of measurement
laboratory CBC
3
Description
platelet count
Timepoint
before chemothrapy and 1 weeks and 2 weeks later
Method of measurement
laboratory CBC
4
Description
drug reaction
Timepoint
before chemothrapy and 1 weeks and 2 weeks later
Method of measurement
questionnaire
5
Description
wbc count
Timepoint
before chemothrapy and 1 weeks and 2 weeks later
Method of measurement
laboratory CBC
Secondary outcomes
1
Description
fever
Timepoint
before chemotherapy and 1 week and 2 weeks later
Method of measurement
questionnaire
2
Description
abdominal pain
Timepoint
before chemotherapy and 1 week and 2 weeks later
Method of measurement
questionnaire
3
Description
dyspnea
Timepoint
before chemotherapy and 1 week and 2 weeks later
Method of measurement
questionnaire
4
Description
bone pain
Timepoint
before chemotherapy and 1 week and 2 weeks later
Method of measurement
questionnaire
5
Description
hypersensitivity reactions
Timepoint
before chemotherapy and 1 week and 2 weeks later
Method of measurement
questionnaire
6
Description
postpone chemotherapy
Timepoint
2 weeks after chemotherapy
Method of measurement
questionnaire
Intervention groups
1
Description
first group:
single dose of 6 mgr Pegagen used after the completion of first course of chemotherapy and 300 ugr G-csf daily for 5 days used at the end of the second course
Category
Treatment - Drugs
2
Description
second group:
after completion of the first course of chemotherapy 300 ugr G-csf daily for 5 days used and at the end of the second course single dose of 6 mgr Pegagen used
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Farzane Ashrafi
Street address
Motahari street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Mrs Mazaheri
Street address
Isfahan University of Medical Sciences, Daneshgah street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mehrzad Salmasi
Position
MD/ Resident of internal medicine
Other areas of specialty/work
Street address
Azahra hospital
City
Isfahan
Postal code
Phone
+98 31 3263 0366
Fax
Email
mehrzad_salmasi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Farzane Ashrafi
Position
Professor of hematology and oncology
Other areas of specialty/work
Street address
Omid hospital
City
Isfahan
Postal code
Phone
+98 31 3235 0214
Fax
Email
farashrafi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehrzad Salmasi
Position
MD/ Residents of internal medicine
Other areas of specialty/work
Street address
Isfahan Azahra Hospital
City
Isfahan
Postal code
Phone
+98 31 3263 0366
Fax
Email
mehrzad_salmasi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)