CTRI/2017/02/007886
Completed
Phase 4
A comparative study of efficacy and safety of Duloxetine 40mg vs Duloxetine 60mg in patients with taxane induced peripheral neuropathy.
Mysore Medical College and Research Institute0 sites44 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Taxane induced peripheral neuropathy
- Sponsor
- Mysore Medical College and Research Institute
- Enrollment
- 44
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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