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

NCT04732455

NAINTERVENTIONAL
Gamal Mohamed Taha Abouelmagd
60 participants
Started 2021-01-15 · Completed 2022-07-05
Status: Completed (as of 12-23-2025)

Conditions

Peripheral NeuropathyChemotherapy-induced Peripheral NeuropathyBreast Cancer

Linked Papers (from SciSciNet-V2)

Total Papers25
Background
10
Result
0
Derived
0
Unknown
15

Total Citations Per Year

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.

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Background Papers20

How to Calculate Sample Size for Different Study Designs in Medical Research?
2013
2,596 citations
How to Calculate Sample Size for Different Study Designs in Medical Research?
2013
2,596 citations
Identifying and Avoiding Bias in Research
2010
900 citations
Identifying and Avoiding Bias in Research
2010
900 citations
Pathophysiology of Chemotherapy-Induced Peripheral Neuropathy
2017
506 citations
Pathophysiology of Chemotherapy-Induced Peripheral Neuropathy
2017
506 citations
Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic or somatic component
2007
199 citations
Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic or somatic component
2007
199 citations
Chemotherapy-Associated Peripheral Neuropathy in Patients With Early-Stage Breast Cancer: A Systematic Review
2017
70 citations
Chemotherapy-Associated Peripheral Neuropathy in Patients With Early-Stage Breast Cancer: A Systematic Review
2017
70 citations
Duloxetine, a Balanced Serotonin-Norepinephrine Reuptake Inhibitor, Improves Painful Chemotherapy-Induced Peripheral Neuropathy by Inhibiting Activation of p38 MAPK and NF-κB
2019
61 citations
Duloxetine, a Balanced Serotonin-Norepinephrine Reuptake Inhibitor, Improves Painful Chemotherapy-Induced Peripheral Neuropathy by Inhibiting Activation of p38 MAPK and NF-κB
2019
61 citations
CLINICAL EVALUATION AND INVESTIGATION OF NEUROPATHY
2003
53 citations
CLINICAL EVALUATION AND INVESTIGATION OF NEUROPATHY
2003
53 citations
Inflammasome Modulation by Chemotherapeutics in Malignant Mesothelioma
2015
44 citations
Inflammasome Modulation by Chemotherapeutics in Malignant Mesothelioma
2015
44 citations
Chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer survivors: a comparison of patient-reported outcomes and quantitative sensory testing
2019
35 citations
Chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer survivors: a comparison of patient-reported outcomes and quantitative sensory testing
2019
35 citations
A Review of the Effects of Pain and Analgesia on Immune System Function and Inflammation: Relevance for Preclinical Studies
2019
26 citations
A Review of the Effects of Pain and Analgesia on Immune System Function and Inflammation: Relevance for Preclinical Studies
2019
26 citations

Result Papers0

No result papers linked

Derived Papers0

No derived papers linked

Unknown Papers15

Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice Guideline
2014
1,118 citations
Allocation concealment in randomised trials: defending against deciphering
2002
853 citations
Development and preliminary validation of a pain measure specific to neuropathic pain
1997
770 citations
Generation of allocation sequences in randomised trials: chance, not choice
2002
701 citations
Chemotherapy-induced peripheral neurotoxicity (CIPN): An update
2011
505 citations
Chemotherapy-induced peripheral neuropathy and its association with quality of life: a systematic review
2014
333 citations
Neuropathic pain in cancer
2013
291 citations
Chemotherapy-induced peripheral neuropathy in patients treated with taxanes and platinum derivatives
2015
183 citations
Efficacy and Safety of Duloxetine in Patients With Chronic Low Back Pain
2010
181 citations
Taxane-induced peripheral neuropathy and health-related quality of life in postoperative breast cancer patients undergoing adjuvant chemotherapy: N-SAS BC 02, a randomized clinical trial
2012
94 citations
Evidence‐based guideline: Treatment of painful diabetic neuropathy—report of the american association of neuromuscular and electrodiagnostic medicine, the american academy of neurology, and the american academy of physical medicine & rehabilitation
2011
78 citations
Intravenous Infusions in Chronic Pain Management
2013
72 citations
Validation of a New Arabic Version of the Neuropathic Pain Diagnostic Questionnaire (DN4)
2016
29 citations
Chemotherapy-induced peripheral neuropathy in newly diagnosed breast cancer survivors treated with taxane: a prospective longitudinal study
2020
25 citations
Intravenous lidocaine affects oxaliplatin pharmacokinetics in simultaneous infusion
2020
4 citations