The therapeutic effects of pregabalin and duloxetine in the treatment of nerve pain caused by certain chemotherapy drugs

Phase 2

• Conditions: Chemotherapy induced peripheral neuropathy.; Polyneuropathy due to other toxic agents

• Registration Number: IRCT201602112027N5
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 82

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.