CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Lidocaine in Saline +2 moredrug
Likely dose
Duloxetine 30 MGfrom record
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Search/NCT04732455
NCT04732455N/ACompleted

Intravenous Lidocaine Infusion Versus Oral Duloxetine For The Prevention And Treatment Of Chemotherapy Induced Peripheral Neuropathy Among Breast Cancer Patients

Gamal Mohamed Taha Abouelmagd·interventional·Posted Feb 1, 2021·Updated Jul 11, 2022

In Brief

A clinical study evaluating Lidocaine in Saline, Duloxetine 30 MG, and 1 other intervention for Peripheral Neuropathy and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The aim of the study is to evaluate the effect of intravenous (IV) lidocaine versus oral duloxetine on the onset and severity of TIPN in patient with breast cancer as well as evaluation of Patients' quality of life and estimation the cell mediated immunity. The current study is a single blinded randomized controlled study, assumed that lidocaine could prevent and reduce TIPN similar to duloxetine in patient with breast cancer. Method of randomization: The allocation sequence was generated using permuted block randomization technique and the block size was variable. Allocation sequence/code was concealed from the person allocating the participants to the intervention arms using sealed opaque envelopes. Primary outcome: Degree of neuropathic pain measured by neuropathy pain scale (NPS) among breast cancer patients on Taxane chemotherapy after the pretreatment with either lidocaine or duloxetine. Secondary outcomes are: The incidence of TIPN using DN4 questionnaire and nerve conduction study and Patients' quality of life using The European Organization for Research and Treatment of Cancer (EORTC) QLQ-CIPN20 as well as the Change in serum level natural killer cell to estimate cell mediated immunity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 1, 2021
Enrollment StartJan 15, 2021
Primary CompletionJun 8, 2022
Study CompletionJul 5, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.4 years ago

Interventions

Lidocaine in Salinedrug

Lidocaine IV infusion (2 mg/kg) in 200 ml saline over forty minutes with a maximum upper limit of 200 mg pre each chemotherapy session until end of the cycle.

Duloxetine 30 MGdrug

Oral Duloxetine tablet 30 mg once per day starting from the night pre chemotherapy during the whole period of chemotherapy cycle which expected to be three month

Normal salinedrug

200 ml normal saline over forty minutes pre each chemotherapy session until end of the cycle.