Comparison of GCSF administration in two methods of daily GCSF versus every other day on cell blood count and patients' pain in patients with breast cancer
Ninety-three female patients between 20 to 50 years old without any renal, liver or cardiac disease, with breast cancer underwent chemotherapy with consent to participate in trial, selected for administration of Granulocyte-colony stimulating factor (GCSF), after finishing first period of chemotherapy receive GCSF subcutaneous every day up to three doses and after another session of chemotherapy receive GCSF every other day up to three doses. Then, hemoglobin, platelet and white blood cell count measured and compared in two methods. pain scores measured by the McGill Pain questionnaire with five score from zero to five.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101830363N1
Registration date:2017-07-14, 1396/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-14, 1396/04/23
Registrant information
Name
Amir Abbas Mahdian
Name of organization / entity
Department of internal medicine, Ahvaz Jundishapur university of medical sciences, Ahvaz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 912 105 2463
Email address
mahdian.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of GCSF administration in two methods of daily GCSF versus every other day on cell blood count and patients' pain in patients with breast cancer
Public title
Comparison of administration of GCSF daily versus every other day, in breast cancer patients' pain and cell blood counts
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: female patients more than 20 years old with breast cancer
Exclusion criteria: Having no consent for taking apart in trial; History of Hypersensitivity to GCSF; Any active infection that may influence on cell blood counts; Patients more than 50 years old; Advanced renal or hepatic impairment or advanced cardiac disease that may have effect on cell blood count or patients ' symptoms and pain.
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur university of medical science
Street address
Golestan Blvd
City
Ahvaz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
th94/10
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast (Breast, unspecified)
Primary outcomes
1
Description
Hemoglobin
Timepoint
One week later
Method of measurement
Cell blood count test
2
Description
Platlet count
Timepoint
One week later
Method of measurement
Cell blood count test
3
Description
White blood cell count
Timepoint
One week later
Method of measurement
Cell blood count test
4
Description
Musculoskeletal pain
Timepoint
One week later
Method of measurement
McGill Pain Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control :Every other day administration of GCSF up to three doses
Category
Treatment - Drugs
2
Description
Intervention : Daily administration of GCSF up to three doses
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Ahmad Ahmad Zade Deilami
Street address
Shafa Hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sceince
Full name of responsible person
Mohammad Taghi Mansoori
Street address
Ahvaz Jundishapur University of Medical Sceince, Golestan Blvd, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sceince
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Tina Vosoghi
Position
Hematology-Oncology Sub Specialist, Assistant Professor
Other areas of specialty/work
Street address
Baghayi Hospital,Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3571 5795
Fax
Email
Vosovghi.hto@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ahmad Ahmadzadeh Deylami
Position
Hematology-Oncology Sub Specialist, Assistant Professor
Other areas of specialty/work
Street address
Baghayi Hosital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
Ahmad.ahmadzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Amir Abbas Mahdian
Position
Specialized in Internal Medicine
Other areas of specialty/work
Street address
Shafa Hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 912 105 2463
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)