]>
IRCT20231227060538N1 IRCT 2024-03-04 Shahid Beheshti University of Medical Sciences 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 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 2024-03-20 anticipated 123 Complete https://irct.ir/trial/74635 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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). 3 Bone Pain Due to PEG G-CSF. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: 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 access period starts 6 months after the results are published To whom: Researchers in academic institutions Conditions: If there is a positive outcome and to need for further studies in this field Where to obtain: 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 How to obtain: 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. Comments:
public Fatemeh Talebian Taheri
South Shahid Madani Ave., Emam Hossin hospital
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 fatimatalebian@ymail.com Shahid Beheshti University of Medical Sciences scientific ّFarnaz Sabrian
Madani Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 6314116177 +98 21 7343 0000 dr.f.saberian@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: patients with solid tumor or lymphoma Candidate for receiving Pegfilgrastim -after chemotherapy based on well known chemotherapy protocol no limit no limit Both 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 C83 Non-follicular lymphoma Treatment - Drugs Treatment - Drugs Treatment - Drugs 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 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. 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. 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. Shahid Beheshti University of Medical Sciences Approved 2024-02-26 The Ethics Committee of the Research and Technology Vice-Chancellor of Shahid Beheshti University of 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 Tehran Tehran Iran (Islamic Republic of)