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IRCT20201128049515N1 IRCT 2020-12-17 Mazandaran University of Medical Sciences The efficacy and safety of Silymarin in chemotherapy-induced peripheral neuropathy (CIPN) The efficacy and safety of Silymarin in chemotherapy-induced peripheral neuropathy (CIPN): a randomized double-blind clinical trial study 2020-12-21 anticipated 80 Complete https://irct.ir/trial/52605 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Those patients who give consent to enter the study will be randomized into blocks of four and sequentially numbered. The randomization code will be held by a third party. Then they will be categorized in two groups of intervention (Silymarin + Gabapentin) and control (Placebo + Gabapentin). Silymarin and placebo will be kept in bottles with previously defined codes and will be handed to participants randomly, Blinding description: This is randomized, double-blind study. Patients and care provider will not be aware of the type of medication (Silymarin or placebo). Patients will be coded randomly into groups of intervention and control separately and their data will be kept in a computer with password. Care provider and patients will not have access to any of these data. Silymarin and placebo will be put in bottles based on patient's code and then will be handed to care provider and then to the patients monthly with no mention to the type of the medicine. Blinding will be applied till the end of the study and statistic analysis. 2-3 Chemotherapy induced peripheral neuropathy in confirmed diagnosed cancer patients.. Intervention 1: Intervention group: 140 mg/day of silymarin (Gol Daru Company, Iran) in two daily doses with 300 mg/day Gabapentin as a standard treatment for peripheral neuropathy for 3 month. Both medications are orally prescribed. Intervention 2: Control group: 300 mg/day of Gabapentin with 140 mg/day of placebo (microcrystalline cellulose) in two daily doses for 3 months. Both medications are orally prescribed. No - There is not a plan to make this available Justification or reason for not sharing IPD is There's no further information.
public Dr Ramin Shekarriz
Cancer comprehensive center, Imam hospital, Amir Mazandarani Blvd, Sari, Iran
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 4044 r.shekarriz@mazums.ac.ir Mazandaran University of Medical Sciences scientific Ramin Shekarriz
Non-communicable disease Institute, 3rd floor, Comprehensive cancer center,Imam hospital, Amir Mazandarani st, Sari, Mazandaran
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 4044 r.shekarriz@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Histologically confirmed diagnosis of cancer At least 18 years of age Having chemotherapy-induced peripheral neuropathy (CIPN). 18 years no limit Both Having a known disease predisposing to neuropathy, including diabetes, neuromuscular disease, vitamin B12 deficiency, amyloidosis, and connective tissue disease, a history of neurological diseases such as hereditary and acquired neuropathies Unbearable side effects of the drug or drug reaction Taking any antioxidant supplement in the last two months Pregnancy, or breastfeeding unwillingness to attend the study G61.1 Serum neuropathy Treatment - Drugs Treatment - Drugs Intervention group: 140 mg/day of silymarin (Gol Daru Company, Iran) in two daily doses with 300 mg/day Gabapentin as a standard treatment for peripheral neuropathy for 3 month. Both medications are orally prescribed. Control group: 300 mg/day of Gabapentin with 140 mg/day of placebo (microcrystalline cellulose) in two daily doses for 3 months. Both medications are orally prescribed. Neuropathy intensity. Timepoint: The first day and 3rd month after the onset of the intervention. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAE) criterion and questionnaire. Quality of life. Timepoint: The first day and the 3rd month after the start of the intervention. Method of measurement: European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ). Pain intensity. Timepoint: The first day and 3rd month after the start of the intervention. Method of measurement: Visual analysis scale (VAS) criterion and questionnaire. Mazandaran University of Medical Sciences Approved 2019-11-27 Ethic committee of Mazandaran University of Medical sciences Comprehensive Cancer Center, Imam hospital, Amir Mazandarani Blvd, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)