Overview

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:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gamal Mohamed Taha Abouelmagd
Treatments:
Duloxetine Hydrochloride
Lidocaine
Criteria
Inclusion Criteria:

- breast cancer

- at any stage,

- Taxane chemo-protocol.

Exclusion Criteria:

- Documented history of gloves and stock neuropathy.

- Alcohol abuse.

- Abnormal renal or liver function tests.

- Allergy to local anesthetics.

- Myocardial infarction within 6 months

- Profound high-grade arrhythmias.

- Patients with neurological or psychological problems.

- Diabetes Mellitus.

- History of previous chemotherapy treatment