Investigating and comparing the effect of three therapeutic methods of Naproxen, hydroxyzine and Syrup Noscough as therapeutic methods for treatment of the bone pain caused by granulocyte-colony stimulating factor(GCSF) in cancer patients
Reducing the amount of pain in neutropenic cancer patients and improving the quality of life, and making it easier to continue treatment
Design
Clinical trial, simple randomized with block method with statistical software, with parallel groups with a sample size of 41 in each group (123in total), trial phase 3
Settings and conduct
Patients include people with solid tumor or lymphoma who are candidates for pegfilgrastim 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 pegfilgrastim by patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with solid tumor or lymphoma Candidate for receiving pegfilgrastim after chemotherapy based on well known chemotherapy protocol. Exclusion criteria: Bone matastasis chronic kidney disease or end stage renal 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 Vitamin D level less than 20
Intervention groups
Control group 1: Hydroxyzine 25 mg orally daily" from the manufacturer of Kimidaru and the duration of use is considered from the onset of pain for 5 days in each of the first 4 cycles of chemotherapy.
Control group 2: naproxen 500 mg every 12 hours orally "Chemidaru manufacturer and duration of use from the onset of pain for 5 days in each of the first 4 cycles of chemotherapy is considered.
The target intervention group (main): noscough syrup 15 cc daily orally, manufactured by Faran Chemi, and the duration of use is considered from the onset of pain for 5 days in each of the first 4 cycles of chemotherapy
Main outcome variables
Amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231227060538N1
Registration date:2024-03-04, 1402/12/14
Registration timing:prospective
Last update:2024-03-04, 1402/12/14
Update count:0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Fatemeh Talebian taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4601 5120
Email address
fatimatalebian@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the effect of three therapeutic methods of Naproxen, hydroxyzine and Syrup Noscough as therapeutic methods for treatment of the bone pain caused by granulocyte-colony stimulating factor(GCSF) in cancer patients
Public title
Investigating and comparing the effect of three therapeutic methods of Naproxen, hydroxyzine and Syrup Noscough as therapeutic methods for preventing bone pain caused by granulocyte-colony stimulating factor(GCSF )in cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: patients with solid tumor or lymphoma Candidate for receiving Pegfilgrastim -after chemotherapy based on well known chemotherapy protocol
Exclusion criteria:
Bone metastasis in patients with progression free survival(PFS )greater than 2
Test-proven osteomalacia
chronic kidney disease or end stage renal disease patients
Patients with active rheumatic disease
diabetes
Uncontrolled thyroid disease
Patients receiving chemotherapy drugs in which bone pain is one of the complications with a high incidence of 10% (TAXAN family, bisphosphonate.)
Patients with pathological fracture or fracture due to any other reason
Opioid addicts
Contraindications for taking naproxen and methadone and other similar drugs
Vitamin D level less than 20
Paget's disease
Hyperparathyroid disease
Patients who have bone pains in the questionnaire with a score above 6 since the beginning of the project
liver disease
Patients with a history of cardiac arrhythmia
Patients who do not have the appropriate admission to fill out the pain questionnaire
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
123
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible subjects will be randomly assigned to one of the three groups receiving noscough, hydroxyzine, and naproxen with a ratio of 1:1:1. The randomization will be in the form of permuted block randomization, with 13 blocks based on the sample size in sizes 3, 6, 9, 12, 15 until the sample size is completed using the "Ralloc" package in STATA software. Patients will be included in each group based on the determined sample size and based on the list of randomized individuals (along with a specific research code for each individual).
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
The Ethics Committee of the Research and Technology Vice-Chancellor of Shahid Beheshti University of
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
2024-02-26, 1402/12/07
Ethics committee reference number
IR.SBMU.MSP.REC.1402.617
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
One day after the end of the first, second, third and fourth course of chemotherapy
Method of measurement
Visual Analogue Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The target intervention group (main): noscough syrup 15 cc daily orally, manufactured by Faran Chemi factory, and the duration of use is considered from the onset of pain for 5 days in each of the first 4 cycles of chemotherapy
Category
Treatment - Drugs
2
Description
Intervention group:Naproxen 500 mg orally every 12 hours "Chemidaru manufacturer and duration of use from the onset of pain for 5 days in each of the first 4 cycles of chemotherapy is considered.
Category
Treatment - Drugs
3
Description
Intervention group:"Hydroxyzine 25 mg daily orally" manufactured by Kimidaro and the duration of use is considered from the onset of pain for 5 days in each of the first 4 cycles of chemotherapy.
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
Fatemeh Talebian Taheri
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
South Shahid Madani Ave., Emam Hossin hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
fatimatalebian@ymail.com
Web page address
https://ehmc.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
ّFarnaz Sabrian
Position
Assistant Professor of Internal Medicine
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Madani Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
6314116177
Phone
+98 21 7343 0000
Email
dr.f.saberian@gmail.com
Web page address
https://ehms.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Talebian Taheri
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Madani Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
fatimatalebian@ymail.com
Web page address
https://ehmc.sbmu.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient information will be entered into the database (Excel format) and after checking the the outliers terms and data cleaning, it will be prepared for statistical analysis. The final data file will be provided to the research unit of internal diseases department to conduct further studies.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers in academic institutions
Under which criteria data/document could be used
If there is a positive outcome and to need for further studies in this field
From where data/document is obtainable
Dr. Fatemeh Talebian Taheri-Imam Hossein Hospital- internal disease clinics
Address:South Shahid Madani Ave., Emam Hossin hospital
Postal code 1617763141
Phone: 02173430000
email: fatimatalebian@ymail.com
Web page address: https://ehmc.sbmu.ac.ir
What processes are involved for a request to access data/document
Through the written request of the applicant to the research department of Imam Hossein Hospital
And after confirming and signing the memorandum of understanding, the data will be available to the applicant within two months.