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IRCT2016050227711N1 IRCT 2016-08-28 Breast Cancer Research Center of Jahad Daneshgahi efficacy of Duloxetine for prevention of chemotherapy induced neuropathy efficacy of Duloxetine for prevention of chemotherapy induced neuropathy in breast cancer patients 2016-07-22 anticipated 116 Complete https://irct.ir/trial/22642 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. 2 breast cancer. Intervention 1: intervention group: duloxetine capsule (Duloxicap produced by Tadbir Kala-e Jam pharmaceutical company) taken orally 30 mg daily starting with first dose of Paclitaxel till 2 weeks after last course of Paclitaxe. Intervention 2: control group: placebo of duloxetine PO daily starting with first dose of Paclitaxel till 2 weeks after last course of Paclitaxe.
public Dr Azin Ahmari
Emam hossein hospital, Shahid madani street
Tehran Iran (Islamic Republic of) +98 21 73430 azin_ahmari@sbmu.ac.irazin_ahmari@yahoo.com Shahid Beheshty University of Medical Sciences scientific Dr Ali Ghanbari Motlagh
Emam Hossein hospital, Shahid madani street
Tehran Iran (Islamic Republic of) +98 21 73430 agmotlagh@sbmu.ac.iragmotlagh@gmail.com Shahid Beheshty University of Medical Siences Iran (Islamic Republic of) Iran (Islamic Republic of) inclusion criteria: -patient receiving paclitaxel -it is the first dose of paclitaxel -prior or ongoing treatment with other neurotoxic chemotherapic agents is not allowed -participants with out any documented medical history of nerve compression, leptomeningeal carcinomatosis, severe depression, suicidal idea, bipolar disease, alcohol abuse, glaucoma, diabetes, thyroid abnormality, markedly abnormal renal or liver function tests - not taking any medicine interfere in serotonin level -not taking any analgesic medicine routinely in two weeks before entering the trial exclusion criteria: -sever complications with duloxetine 18 years 80 years Both C50 Malignant neoplasm of breast Treatment - Drugs Placebo intervention group: duloxetine capsule (Duloxicap produced by Tadbir Kala-e Jam pharmaceutical company) taken orally 30 mg daily starting with first dose of Paclitaxel till 2 weeks after last course of Paclitaxe control group: placebo of duloxetine PO daily starting with first dose of Paclitaxel till 2 weeks after last course of Paclitaxe Neuropathy. Timepoint: before satrting intervention and 6-12-24 weeks after that. Method of measurement: NCI-CTCAE and FACT-TAXAN questionnaire. Quality of life. Timepoint: before starting intervention and in 6-12-24 weeks after that. Method of measurement: FACT-TAXAN questionnaire. Tadbir Kalay-e Jam Pharmaceutical Company Breast Cancer Research Center of Jahad Daneshgahi Tadbir Kalay-e Jam Pharmaceutical Company Approved 2010-09-23 Ethics committee of Tehran University of Medical Siences Breast Cancer Research Center of Jahad Daneshgahi, number 146, South Gandi street, Vanak square Tehran Iran (Islamic Republic of)