IRCT201602112027N5 IRCT 2016-07-13 Mazandaran University of Medical Sciences The therapeutic effects of pregabalin and duloxetine in the treatment of nerve pain caused by certain chemotherapy drugs Comparison of the therapeutic efficacy of pregabalin and duloxetine in peripheral neuropathy induced by taxanes containing chemotherapy regimens in women with breast cancer, a randomized clinical trial. 2015-12-22 anticipated 82 Complete https://irct.ir/trial/1651 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Chemotherapy induced peripheral neuropathy. Intervention 1: Intervention group 1: Pregabalin 75 mg/day orally for the first week and 75 mg BD (max: 75 mg TDS) for the next for 6 weeks. Intervention 2: Intervention group 2: Duloxetine 30 mg/day orally for the first week and 30 mg BD for the next for 6 weeks.

public Salehifar Ebrahim

Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province

Sari Iran (Islamic Republic of) +98 11 3354 3082 Esalehifar@Mazums.ac.ir; Salehifare@yahoo.com; esalehifar52@gmail.com Mazandaran University of Medical Sciences, Faculty of Pharmacy Iran (Islamic Republic of) Inclusion criteria: Age of more than 18 y; NCI Common Terminology Criteria for Adverse Events scale (NCI grade> 1); Minimum rating of NRS scale: 4 (0-10) Exclusion criteria: Having other clinical conditions that cause neuropathies, such as diabetes or trauma; Alcohol abuse; History of central nervous system diseases; History of heart, hepatic and renal failure (creatinine clearance below 60ml/min); History of glaucoma; History of depression, anxiety, bipolar, psychotic disorders and suicidal ideation; Receiving other neurotoxic chemotherapy drugs; Having concomitant use of MAOI, BZD and gabapentin; Females during pregnancy or lactation; Patients who have received pregabalin or duloxetine in recent 15 days; Having concomitant use of analgesics or effective on nerve activity drugs such as vitamin B12, lamotrigine, valproate and TCA (except pregabalin or duloxetine) will be excluded if they spent a total of 7 days washout, the patients also can be studied; Concomitant use of selected analgesics was allowed (eg, nonsteroidal anti-inflammatory drugs , acetaminophen, aspirin,..) but only patients receiving stable doses in the 2 weeks before randomization could participate: (1) no new analgesics were added, (2) no analgesics were discontinued and (3) the weekly 24-hour total analgesic dose did not fluctuate up or down by more than 10% in the 2weeks before study registration 18 years no limit Female 62.2 Polyneuropathy due to other toxic agents Treatment - Drugs Treatment - Drugs Intervention group 1: Pregabalin 75 mg/day orally for the first week and 75 mg BD (max: 75 mg TDS) for the next for 6 weeks Intervention group 2: Duloxetine 30 mg/day orally for the first week and 30 mg BD for the next for 6 weeks Sensory neuropathy. Timepoint: Before intervention, three weeks after intervention and six weeks after intervention. Method of measurement: According to the NCI Common Terminology Criteria for Adverse Events grading scale. Neuropathic pain. Timepoint: Before intervention, three weeks after intervention and six weeks after intervention. Method of measurement: Visual Analogue Scale. Quality of life. Timepoint: Before intervention, three weeks after intervention and six weeks after intervention. Method of measurement: EORTC QLQ-C30 (Version 3) questionnaire. Side effects. Timepoint: Three weeks after intervention and six weeks after intervention. Method of measurement: Questionnaire. Mazandaran University of Medical Sciences Approved 2016-01-26 Ethics Committee of Mazandaran University of Medical Sciences, Faculty of Pharmacy Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province Sari Iran (Islamic Republic of)