Chemotherapy induced peripheral neuropathy. Polyneuropathy due to other toxic agents
Conditions
Interventions
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
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
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSalehifar Ebrahim
Mazandaran University of Medical Sciences, Faculty of Pharmacy
Outcome results
None listed