comparison of the efficacy and complication of two medication regimen 'naproxen and loratadin’ with 'acetaminophen and loratadin' on relief of bone pain due to PEG G-csf in patients with solid tumors chemotherapy
Reducing the amount of pain in neutropenic cancer patients and improving the quality of life, and making it easier to continue treatment with a less complicated drug like Acetaminophen for these patients.
Design
Clinical trial, simple randomized with block method with statistical software, with parallel groups with a sample size of 100 in each group (200 in total), trial phase 3
Settings and conduct
Patients include people with solid tomor or lymphoma who are candidates for PEGG-CSF after chemotherapy based on valid chemotherapy protocol and refer to the Imam Hossein Hospital chemotherapy center in Tehran.
The method of this study was to fill the pain questionnaire before, during and after treatment with PEG G-CSF by patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with solid tumor or lymphoma
Candidate for receiving PEG G-CSF after chemotherapy based on well known
chemotherapy protocol.
Exclusion criteria:
Bone matastasis
CKD or ESRD
Patients receiving chemotherapy drugs that have bone pain are a high prevalence of 10% (TAXAN family, bisphosphonate ...)
Pathologic fracture or fracture due to any reason
Vitamin D level less than 20
Intervention groups
A group treated with acetaminophen and loratadine
A group treated with naproxen and loratadine
Main outcome variables
Amount of pain in the group treated with Acetaminophen and Loratadine
Complications of acetaminophen and loratadine group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190514043586N1
Registration date:2019-05-31, 1398/03/10
Registration timing:prospective
Last update:2019-05-31, 1398/03/10
Update count:0
Registration date
2019-05-31, 1398/03/10
Registrant information
Name
seyyed saeid noorani yazdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3521 0445
Email address
s.noorani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the efficacy and complication of two medication regimen 'naproxen and loratadin’ with 'acetaminophen and loratadin' on relief of bone pain due to PEG G-csf in patients with solid tumors chemotherapy
Public title
Effect of Acetaminophen on relief of bone pain due to PEG G-CSF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with Solid Tumor or Lymphoma who receive PEG G-CSF due to neutropenia after chemotherapy
Exclusion criteria:
Bone matastasis
PFS more than 2
Osteomalacia proven with laboratory tests
CKD or ESRD
Active Rheumatologic disease
Uncontrolled Diabetes or Thyroid disease
Patients receiving chemotherapy drugs that have bone pain are a high prevalence of 10% (TAXAN family, bisphosphonate ...)
Pathologic fracture or fracture due to any reason
Naproxen use contraindication
Vitamin D level less than 20
Paget disease
Hyperparathyroidism
People who have had a score of over 6 in the bone pain score since the beginning of the project
Liver disease
History of Cardiac Arrhythmia
Patient who have not compliance for completing pain questionnaire
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected through available sampling method and are assigned to one of the two treatment groups using a simple accident method with blocks with block size 2. In this method, by referring each patient to the clinic, a card of size 2 will be taken randomly by the researcher and, depending on how the order is written on the card, the patient is assigned to group 1 or 2. The randomization unit here is the person participating in the study and there is no layer randomization. The randomization tool is a ready-made card that the researcher randomly takes them and ensures a random sequence of people entering the study. Hiding for the patient and researcher is not applicable here, but for the statistical analyst, hiding is carried out, and the data for the two groups of patients are presented to him as groups A and B.
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
Vice-Chancellor in Research Affairs-Shahid Beheshti University of Medical Scieences
Street address
13th floor, block A, Central staff of Ministry of Health and Medical Education, Simaye Iran Ave., between south Falamak and Zarafshan AVE., Qods(gharb) town
City
Tehran
Province
Tehran
Postal code
1615633156
Approval date
2019-04-14, 1398/01/25
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.010
Health conditions studied
1
Description of health condition studied
Bone Pain Due to PEG G-CSF
ICD-10 code
C83
ICD-10 code description
Non-follicular lymphoma
Primary outcomes
1
Description
Pain Score in Visual Analogue Scale(VAS) questionnaire
Timepoint
Day 0; One day after the end of first and third course of chemotherapy
Method of measurement
Visual Analogue Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:Tab Acetaminophene 500 mg orally every 6 hours +Tab Loratadine 10 mg orally daily, from Kimidarou manufacturer, duration of drug use is from pain onset to 48 hours after pain relief.
Category
Treatment - Drugs
2
Description
Intervention group2: Tab Naproxene 500 mg orally every 12 hours +Tab Loratadine 10 mg orally daily,from Kimidarou manufacturer, duration of drug use is from pain onset to 48 hours after pain relief.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein hospital
Full name of responsible person
Seyed Saeid Noorani Yazdi
Street address
South Shahid Madani Ave., Emam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
dr.saeid.noorani@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University Of Medical Science, Arabi Ave., Yaman Ave., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Amir Sheykholeslami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
South Shahid Madani Ave., Emam Hossin hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
amirsheikholeslami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Amir Sheykholeslami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
South Shahid Madani Ave., Emam Hossin hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
amirsheikholeslami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Amir Sheykholeslami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
South Shahid Madani Ave., Emam Hossin hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
amirsheikholeslami@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
No more information
When the data will become available and for how long
One Year After Publish of Rsults
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For studying and treating patients
From where data/document is obtainable
E-mail:dr.saeid.noorani@gmail.com
What processes are involved for a request to access data/document
Sign in to the clinical trial site and search for keywords