Health Condition 1: null- Taxane induced peripheral neuropathy
Conditions
Interventions
Intervention1: T.Duloxetine 60mg: T.Duloxetine 60mg orally once daily at night after food for 6 weeks.
Control Intervention1: T.Duloxetine 40mg: T.Duloxetine 40mg orally once daily at night after food
Sponsors
Mysore Medical College and Research Institute
Dr Hema NG
Dr Mukesh S
Eligibility
Inclusion criteria
Inclusion criteria: 1)Age > 18 years of age. 2)All patients who received Paclitaxel 175mg/m2 and should have developed peripheral neuropathy due to paclitaxel. 3)Had > grade 1 sensory CIPN based on NCI Common Toxicity Criteria for Adverse Events (CTCAE) V.4.0. grading scale. 4)Patients with any cancer diagnosis or stage . 5)No precedent peripheral neuropathy.
Exclusion criteria
Exclusion criteria: Participants with a documented medical history of 1)Preceding neuropathy due to Diabetes mellitus. 2)Neuropathy from any other type of nerve compression ( eg. Carpal / tarsal tunnel syndrome, radiculopathy , spinal stenosis, brachial plexopathy). 3)Severe depression. 4)Suicidal ideation. 5)Bipolar disorder. 6)Alcohol abuse. 7)Markedly abnormal renal or liver function test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EfficacyTimepoint: Baseline (before medication),2nd week, 4th week and 6th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effect profileTimepoint: 2nd week, 4th week and 6th week. | — |
Countries
India
Contacts
Public ContactDr Latha kamath
Mysore Medical College and Research Institute
Outcome results
None listed