Comparison of the effect of Non-steroidal analgesics alone with Loratadine combined with Non-steroidal analgesics in the prevention of pain caused by Granulocyte colony stimulating factor in cancer patients
Comparison of the effect of Non-steroidal analgesics alone with Loratadine combined with Non-steroidal analgesics in the prevention of pain caused by Granulocyte colony stimulating factor in cancer patients
Design
Clinical trial with control group, with parallel groups, not blinded.
The study phase is 3. Simple randomization using the Graphpad site is used.
The study is performed on 70 cancer patients undergoing chemotherapy in two groups. One group received Naproxen and Loratadine and the other received Naproxen.
Settings and conduct
It is performed at Shahid Rajaei Training Center in Karaj. The first group will receive Naproxen 500 milligram (mg) twice daily with Loratadine 10 mg once daily and the second group will receive Naproxen 500 mg twice daily for 8 days after receiving Granulocyte colony stimulating factor. Pain severity after receiving Naproxen and Loratadine is measured based on McGill pain questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age 18 or older, presence of malignancy confirmed by pathological reports and receiving chemotherapy drugs and Granulocyte colony stimulating factor; and non-inclusion criteria include history of chronic pain, bleeding or gastrointestinal ulcer, hypersensitivity to antihistamines.
Intervention groups
The first group will receive Naproxen with Loratadine and the second group will receive Naproxen for 8 days after receiving Granulocyte colony stimulating factor.
Main outcome variables
Pain severity due to Granulocyte colony stimulating factor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190922044848N1
Registration date:2019-10-05, 1398/07/13
Registration timing:retrospective
Last update:2019-10-05, 1398/07/13
Update count:0
Registration date
2019-10-05, 1398/07/13
Registrant information
Name
Fateme Atefrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8840 7199
Email address
m.assadi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
2018-11-19, 1397/08/28
Actual recruitment end date
2019-03-16, 1397/12/25
Trial completion date
2019-04-09, 1398/01/20
Scientific title
Comparison of the effect of Non-steroidal analgesics alone with Loratadine combined with Non-steroidal analgesics in the prevention of pain caused by Granulocyte colony stimulating factor in cancer patients
Public title
The effect of Loratadine and Naproxen on prevention of pain caused by Granulocyte colony stimulating factor in cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are 18 years of age or older
Patients with malignancy confirmed by pathological reports
Patients receiving chemotherapy drugs and Granulocyte colony stimulating factor
Exclusion criteria:
Patients with a history of chronic pain
Patients with a history of gastrointestinal bleeding or ulcers
Patients who have a history of intolerance or hypersensitivity to antihistamines
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was performed using the random sequence created by the graphpad site.(https://www.graphpad.com/quickcalcs/randomize1)
It is an individual randomization unit.
Allocation concealment was performed using sequentially numbered, sealed, opaque envelopes.
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 Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, West Bou Ali Street, Nabovat Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149969415
Approval date
2018-11-17, 1397/08/26
Ethics committee reference number
IR.ABZUMS.REC.1397.128
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
2
Description of health condition studied
Multiple myeloma
ICD-10 code
C90
ICD-10 code description
Multiple myeloma and malignant plasma cell neoplasms
3
Description of health condition studied
Hodgkin lymphoma
ICD-10 code
C81
ICD-10 code description
Hodgkin lymphoma
4
Description of health condition studied
Follicular lymphoma
ICD-10 code
C82
ICD-10 code description
Follicular lymphoma
5
Description of health condition studied
Non-follicular lymphoma
ICD-10 code
C83
ICD-10 code description
Non-follicular lymphoma
6
Description of health condition studied
Ovarian cancer
ICD-10 code
C56
ICD-10 code description
Malignant neoplasm of ovary
7
Description of health condition studied
Vaginal cancer
ICD-10 code
C52
ICD-10 code description
Malignant neoplasm of vagina
8
Description of health condition studied
Bladder cancer
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
Primary outcomes
1
Description
Pain severity due to Granulocyte colony stimulating factor
Timepoint
Measurement of pain severity 9 days after receiving Granulocyte colony stimulating factor
Method of measurement
McGill pain questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 35 cancer patients are randomly assigned into this group. Naproxen 500 milligram twice daily with Loratadine 10 milligram once daily is prescribed orally for 8 days after receiving Granulocyte colony stimulating factor. Loratadine and Naproxen manufactured by Abidi Pharmaceutical Company from Iran are used in the study.
Category
Prevention
2
Description
Control group: 35 cancer patients are randomly assigned into this group. Naproxen 500 milligram twice daily is prescribed orally for 8 days after receiving Granulocyte colony stimulating factor. Naproxen manufactured by Abidi Pharmaceutical Company from Iran is used in the study.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Training Center of Karaj
Full name of responsible person
Fariba Rahimi
Street address
Hesarak, Shahid Rajaei Street, Shahid Rajaei Training Center
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
+98 26 3457 0030
Email
frahimi110@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Noorisepehr
Street address
Vice Chancellor for Research and Technology of Alborz University of Medical Sciences, Saffarian Alley, 45 Meter Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 4083
Email
dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
10
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
Karaj University of Medical Sciences
Full name of responsible person
Fateme Atefrad
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 50, Nowruzifard Street, Heydari Street, Janbazan West Street, Tehran
City
Tehran
Province
Tehran
Postal code
1636818314
Phone
+98 21 8840 7199
Fax
Email
fa.atefrad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fateme Atefrad
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 50, Nowruzifard Street, Heydari Street, Janbazan West Street, Tehran
City
Tehran
Province
Tehran
Postal code
1636818314
Phone
+98 21 8840 7199
Fax
Email
fa.atefrad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fateme Atefrad
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 50, Nowruzifard Street, Heydari Street, Janbazan West Street, Tehran
City
Tehran
Province
Tehran
Postal code
1636818314
Phone
+98 21 8840 7199
Fax
Email
fa.atefrad@gmail.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