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Comparison of the effect of pegfilgrastim with filgrastim on the neutrophil count of cancer patients under chemotherapy, a randomization clinical trial.

Protocol summary

Study aim
Comparison of the effect of pegfilgrastim with filgrastim on the neutrophil count of cancer patients under chemotherapy.
Design
Clinical trial with 2 intervention group, randomised, parallel group, phase 3 on 60 patients, permuted blocks are used for randomization.
Settings and conduct
this clinical trial that will be performed in Kosar Semnan. At the beginning of the study, the demographic information of all patients and the primary CBC test are recorded in the data collection form. Patients are then randomly divided into two groups 1 and 2. Intervention group 1: Patients are in this group for a period of chemotherapy. For patients 24 hours after chemotherapy, 5 ug/kg of filgrastim is prescribed for 4 days. Intervention group 2: Patients are in this group for a period of chemotherapy. For patients 24 hours after chemotherapy, a single dose of 6 mg of pegfilgrastim is prescribed. Patients are followed up until the next round of chemotherapy, and before starting the next round of chemotherapy, the CBC test is retaken and recorded in the data collection form.
Participants/Inclusion and exclusion criteria
Having satisfaction, Age over 18 years, Chemotherapy in Omid ward of Kowsar hospital, History of at least 1 course of chemotherapy, Use myelosuppression chemotherapy drugs, Lack of allergy to pegfilrastim and filgrastim, Absence of underlying diseases
Intervention groups
Intervention group 1: Patients are in this group for a period of chemotherapy. For patients 24 hours after chemotherapy, 5 ug/kg of filgrastim (brand name: Tinagrast, a product of Arya Tina Gene Pharmaceutical Company) is prescribed for 4 days. Intervention group 2: Patients are in this group for a period of chemotherapy. For patients 24 hours after chemotherapy, a single dose of 6 mg of pegfilgrastim (brand name: Pagagen, a product of Sinagen Pharmaceutical Company) is prescribed.
Main outcome variables
Neutrophil count.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180119038433N3
Registration date: 2020-09-26, 1399/07/05
Registration timing: prospective

Last update: 2020-09-26, 1399/07/05
Update count: 0
Registration date
2020-09-26, 1399/07/05
Registrant information
Name
Amin Izadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3346 5228
Email address
aminizadi1374@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of pegfilgrastim with filgrastim on the neutrophil count of cancer patients under chemotherapy, a randomization clinical trial.
Public title
Comparison of the effect of pegfilgrastim with filgrastim on the neutrophil count of cancer patients under chemotherapy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having satisfaction Age over 18 years Chemotherapy in Omid ward of Kowsar hospital History of at least 1 course of chemotherapy Use myelosuppression chemotherapy drugs Lack of allergy to pegfilrastim and filgrastim Absence of underlying diseases
Exclusion criteria:
Patients with underlying disease Allergy to pegfilgrastim or filgrastim Severe fever and neutropenia in previous courses of chemotherapy Patients with advanced cancer Not consent to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by permutation block method. It is an individual randomization unit. In this study, 4 blocks are used that have six modes (P,P,F,F and P,F,P,F and P,F,F,P and F,P,F,P and F,F,P,P and F, P, P, F) occurs, when we write each state on a card. Due to the fact that the sample size is 60 people, the above cards are used 15 times with replacement. The cards are selected using a random number table. (P= Pegfilgrastim group, F= Filgerastim group)
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
Ethics committee of Semnan University of Medical Sciences
Street address
Basij Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.SEMUMS.REC.1399.160

Health conditions studied

1

Description of health condition studied
Chemotherapy
ICD-10 code
Z51.1
ICD-10 code description
Encounter for antineoplastic chemotherapy and immunotherapy

Primary outcomes

1

Description
Neutrophil count.
Timepoint
Before the intervention and before the next round of chemotherapy.
Method of measurement
Complete Blood cell count and Diffrential count.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients are in this group for a period of chemotherapy. For patients 24 hours after chemotherapy, 5 ug/kg of filgrastim (brand name: Tinagrast, a product of Arya Tina Gene Pharmaceutical Company) is prescribed for 4 days.
Category
Treatment - Drugs

2

Description
Intervention group: Patients are in this group for a period of chemotherapy. For patients 24 hours after chemotherapy, a single dose of 6 mg of pegfilgrastim (brand name: Pagagen, a product of Sinagen Pharmaceutical Company) is prescribed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar hospital of Semnan
Full name of responsible person
Mohammad Amir Sarabi
Street address
Kowsar hospital, Amin Blvd.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2001
Email
kosarhos@semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Basij Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 0225
Fax
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Amir Sarabi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Kowsar hospital, Amin Blvd.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2001
Email
drsam_amir@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Amir Sarabi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Amin Blvd
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2001
Email
drsam_amir@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Amir Sarabi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Amin Blvd.
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2001
Email
drsam_amir@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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