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IRCT20201115049390N1 IRCT 2021-01-23 Kashan University of Medical Sciences effect of dulexetine on paclitaxel- induced peripheral Neuropathy Effect of duloxetine on paclitaxel- induced peripheral Neuropathy Among women with breast cancer. 2020-11-30 anticipated 60 Complete https://irct.ir/trial/52359 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Other design features: The main feature of this study is that there are two groups: parallel and crassover, Randomization description: patients will be randomly placed in one of four groups (n = 15). (To prevent data loss, 15 patients will be placed in each group and all groups will be matched with each other.) The type of study intended to eliminate the "Carryover" side effect of the previous drug was determined by the "Crossover-Clinical trial" designed by Balaam's design. The subjects will be determined based on the sample size formula and will be grouped into one of four sequences (A, B, C, D) in a simple random assignment, Blinding description: The drugs are prepared as original dulexetin and placebo. No information is given to the patient or nurse about the type of medication and only the researcher knew the type. 3 Paclitaxel induced peripheral neuropathy. Intervention 1: Intervention group: Patients with taxol-induced peripheral neuropathy who take dolextin 60 daily for two weeks. at the beginning and the end of the test, the patient's TNF alphaf will be measured . Intervention 2: Control group: Patients with taxol-induced peripheral neuropathy who are treated with placebo, will take it daily for two weeks and TNF-alpha measured at the beginning and end of the test. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no more information
public Zahra rezaiyan
Department of Physiology, Faculty of Medicine, University of Medical Sciences, Qutb Ravandi Blvd., Kashan, Iran
Isfahan Iran (Islamic Republic of) 88141- 87159 +98 31 5554 0021 N.rezaii2202@gmail.com Kashan University of Medical Sciences scientific Gholamali Hamidi
Department of Physiology, Faculty of Medicine, University of Medical Sciences, Qutb Ravandi Blvd., Kashan, Iran
Kashan Iran (Islamic Republic of) 88141- 87159 +98 31 5554 0021 Hamidi_gh@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) 1- Women with breast cancer (according to the pathological tests and graphies) Treat with paclitaxel 80 mg once a week checked with Beck Depression Inventory (BDI-II) . not treated any other chemotherapy drugs with Life expectancy over than 6 months 18 years no limit Female Pregnant or breastfeeding women Women with a history of diabetes or peripheral vascular disease Woman with a history of liver and kidney disease Woman with a history of Psychiatric diseases such as bipolar disorder woman a history of peripheral nerve disease such as carpal tunnel G60-G64 Polyneuropathy (diseases of several nerves) and other disorders of the peripheral nervous system Treatment - Drugs Treatment - Drugs Intervention group: Patients with taxol-induced peripheral neuropathy who take dolextin 60 daily for two weeks. at the beginning and the end of the test, the patient's TNF alphaf will be measured . Control group: Patients with taxol-induced peripheral neuropathy who are treated with placebo, will take it daily for two weeks and TNF-alpha measured at the beginning and end of the test. Reducing peripheral neuropathy pain. Timepoint: Evaluation of neuropathic pain at the beginning and end of the intervention with measurement of TNF at the beginning and end of the intervention in two parallel groups. Method of measurement: Using( The Brief Pain Inventory); ( National Cancer Institute-Common Toxicity Criteria); von Frey or monofilament test; Visual analog scale; TNF alpha ELISA Kits. Kashan University of Medical Sciences Approved 2020-10-28 Ethics committee of kashan University of Medical Sciences 5th of Qotb –e Ravandi Blvd, Kashan, IRAN Kashan Isfehan Iran (Islamic Republic of)