Lidocaine Versus Duloxetine for the Prevention of Taxane-Induced Peripheral Neuropathy In Breast Cancer Patients

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.

Conditions

• Peripheral Neuropathy
• Chemotherapy-induced Peripheral Neuropathy
• Breast Cancer

Interventions

DRUG

Lidocaine in Saline

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.

DRUG

Duloxetine 30 MG

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

DRUG

Normal saline

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

Sponsors & Collaborators

• Gamal Mohamed Taha Abouelmagd

  lead OTHER

Principal Investigators

• Sahar A El-Karadawy, MD · Medical Research Institute - MRI

• Magda M Abo-Ollo, MD · Medical Research Institute - MRI

• Wessam Z. Alamrawy, MD · Medical Research Institute - MRI

• Yasmine N. Elwany, MD · Medical Research Institute - MRI

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-15

Primary Completion

2022-06-08

Completion

2022-07-05

Countries

• Egypt

Study Locations