NCT04732455: TIPN

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

Completed NA Last updated 11 July 2022

What this trial tests

NA trial testing Lidocaine in Saline in Peripheral Neuropathy in 60 participants. Completed in 5 July 2022.

Timeline

15 January 2021

Primary endpoint
8 June 2022

5 July 2022

Quick facts

Lead sponsor	Gamal Mohamed Taha Abouelmagd
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	60
Start date	15 January 2021
Primary completion	8 June 2022
Estimated completion	5 July 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Lidocaine in Saline — full drug profile →
• Duloxetine 30 MG — full drug profile →
• Normal saline

Conditions studied

• Peripheral Neuropathy — all drugs for Peripheral Neuropathy →
• Chemotherapy-induced Peripheral Neuropathy — all drugs for Chemotherapy-induced Peripheral Neuropathy →
• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Gamal Mohamed Taha Abouelmagd — full company profile →

Who can join

Adults 18 to 65, female only, with Peripheral Neuropathy or Chemotherapy-induced Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integrated Medicine for Chemotherapy-Induced Peripheral Neuropathy.
   Tsai CH, Lin YH, Li YS, Ho TL, et al · · 2021 · cited 12× · PMID 34502166 · DOI 10.3390/ijms22179257
2. Lidocaine Infusion Versus Duloxetine for Prevention and Management of Taxane-Induced Peripheral Neuropathy among Breast Cancer Patients-A Randomized Controlled Study.
   Abouelmagd GMT, El-Karadawy SA, Abo-Ollo MM, Elwany YN, et al · · 2023 · cited 5× · PMID 37774185 · DOI 10.36076/ppj.2023.26.e497
3. Chemotherapy-induced peripheral neuropathy in patients with breast cancer treated with taxanes (Review).
   Godiveau M, Jahanmohan JP, Abrial C, Durando X. · · 2025 · cited 2× · PMID 40949893 · DOI 10.3892/ol.2025.15254