Prevention of Oxaliplatin Induced Peripheral Neuropathy (OIPN)

Phase 3

• Conditions: Oxaliplatin Induced Peripheral Neuropathy (OIPN).; Other anti neoplastic drugs

• Registration Number: IRCT20170211032494N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 January 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Patients have pathologically confirmed cancer; Aged 18-75; Candidate for receiving at least 4 courses of Oxaliplatin; Good performance status (based on ECOG)

Exclusion Criteria

History of diabetes mellitus; Previous neuropathy; Chronic renal or liver disease; Consumption of neurotoxic/neurotropic/neuroleptic drugs

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxaliplatin Induced Peripheral Neuropathy (OIPN). Timepoint: Before, During and after each chemotherapy cycle, 6 weeks after last chemotherapy cycle. Method of measurement: Subjective evaluation by Common Terminology Criteria for Adverse Effect, Objective assessment by Nerve Conducting Study.

Secondary Outcome Measures

Name	Time	Method
Safety profile of Duloxetine. Timepoint: Before, During and after each chemotherapy cycle, 6 weeks after last chemotherapy cycle. Method of measurement: Questionnaire.