Lidocaine Versus Duloxetine for the Prevention of Taxane-Induced Peripheral Neuropathy In Breast Cancer Patients
Status:
Recruiting
Trial end date:
2021-09-15
Target enrollment:
Participant gender:
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.