A clinical trial to study the effects of two doses of a drug Duloxetine in peripheral neuropathic pain in patients undergoing treatment with Taxane (anticancer drug).
Phase 4
Completed
- Conditions
- Health Condition 1: null- Taxane induced peripheral neuropathy
- Registration Number
- CTRI/2017/02/007886
- Lead Sponsor
- Mysore Medical College and Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method