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

NCT04732455 | Completed DMC

• 1 other identifier: 1216-4-011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast cancer; Chemotherapy; Lidocaine; Duloxetine; Taxane induced peripheral neuropathy (TIPN)

Outcome Measures

Primary Outcomes (1)

• Change in Neuropathic pain characters and severity

  The change in intensity and characters of neuropathic pain will be measured using Neuropathy Pain Scale (NPS). It quantifies severity of neuropathic pain (0 indicates no pain, 10 indicates the most pain imaginable).

  every week for 12 weeks (after each chemotherapy session)

Secondary Outcomes (6)

• Quality of life assessment using the European Organization for Research and Treatment of Cancer - Quality of life questioner - Chemotherapy induced peripheral neuropathy twenty-item scale(EORTC - QLQ - CIPN20 ).

  Baseline (before starting chemotherapy protocol), one month ,two month and at 12 weeks ( end of chemotherapy cycle)

• Detection of Chemotherapy induced peripheral neuropathy using sensory nerve conduction latency study .

  Baseline (before starting chemotherapy protocol) then 12 weeks later ( end of chemotherapy cycle)

• Detection of Chemotherapy induced peripheral neuropathy using sensory nerve conduction amplitude study .

  Baseline (before starting chemotherapy protocol) then 12 weeks later ( end of chemotherapy cycle)

• Detection of Chemotherapy induced peripheral neuropathy using sensory nerve conduction velocity study .

  Baseline (before starting chemotherapy protocol) then 12 weeks later ( end of chemotherapy cycle)

• Incidence of Taxane induced peripheral neuropathy (TIPN) using Douleur Neuropathique 4 questionnaire (DN4)

  Baseline (before starting chemotherapy protocol), then every week for 12 weeks (after each chemotherapy session)

Study Arms (3)

Group Control (C)

PLACEBO COMPARATOR

20 adult breast cancer patients on Taxane chemo protocol will receive 200 ml normal saline over forty minutes pre each chemotherapy session until end of the cycle.

Drug: Normal saline

Group lidocaine infusion (L)

EXPERIMENTAL

20 adult breast cancer patients on Taxane chemo protocol will receive lidocaine i.v infusion (2 mg/kg) in 200ml saline over forty minutes with a maximum upper limit of 200 mg pre each chemotherapy session until end of the cycle. If any selected patient reported neuropathic pain (DN4 \> 4) during the course of chemotherapy lidocaine (2 mg/kg) re-infused after each session. If lidocaine side effects such as circumoral numbness, twitches, metal test, tachy or bradycardia recorded at any time, lidocaine infusion will be reduced to 1mg/kg, if side effects persist, the patients will be managed accordingly as well as lidocaine infusion will be stopped and patient will be excluded from the study.

Drug: Lidocaine in Saline

Group duloxetine (D)

EXPERIMENTAL

20 adult breast cancer patients on chemotherapy will take oral duloxetine tablet 30 mg once per day starting from the night pre chemotherapy session until the end of cycle. If any selected patient reported neuropathic pain (DN4 \> 4) during the course of chemotherapy the duloxetine dose will be adjusted to 60 mg daily till the end of the cycle. They also will receive 200 ml normal saline over forty minutes before each chemotherapy session until end of the cycle.

Drug: Duloxetine 30 MG

Interventions

Lidocaine in Saline DRUG

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.

Also known as: L

Group lidocaine infusion (L)

Duloxetine 30 MG DRUG

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

Also known as: D

Group duloxetine (D)

Normal saline DRUG

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

Also known as: C

Group Control (C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• breast cancer
• at any stage,
• Taxane chemo-protocol.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gamal Mohamed Taha Abouelmagd: lead

Study Sites (1)

Egypt Medical Research Institute

Alexandria, Egypt

Location

Related Publications (28)

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  PMID: 24494204 RESULT

• Abouelmagd GMT, El-Karadawy SA, Abo-Ollo MM, Elwany YN, Mohamed ER, El-Amrawy WZ. Lidocaine Infusion Versus Duloxetine for Prevention and Management of Taxane-Induced Peripheral Neuropathy among Breast Cancer Patients-A Randomized Controlled Study. Pain Physician. 2023 Sep;26(5):E497-E507.

  PMID: 37774185 DERIVED

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Breast Neoplasms

Interventions

Lidocaine; Sodium Chloride; Duloxetine Hydrochloride; Fumigant 93; Saline Solution

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sahar A El-Karadawy, MD

  Medical Research Institute - MRI

  STUDY DIRECTOR

• Magda M Abo-Ollo, MD

  Medical Research Institute - MRI

  STUDY DIRECTOR

• Wessam Z. Alamrawy, MD

  Medical Research Institute - MRI

  STUDY DIRECTOR

• Yasmine N. Elwany, MD

  Medical Research Institute - MRI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc Anaesthesia and Surgical Intensive Care

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: February 1, 2021
• Study Start: January 15, 2021
• Primary Completion: June 8, 2022
• Study Completion: July 5, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available once collected and reported in study database.
• Access Criteria: All IPD collected can be shared with other researchers in other studies as described by the main investigators. Personal data will never be shared.

Locations

EG (1)