Taxane-induced neuropathy.
Conditions
Interventions
Intervention 1: Intervention group who suffers from taxane-induced neuropathy, the standard treatment is duloxetine 30 mg daily in the first week and then 60 mg daily with lacosamide drug of Abidi Ph
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: People aged 18 years and older Patients with taxane-induced peripheral neuropathy Existence of moderate to severe neuropathic pain with PI-NRS score =4 Normal baseline ECG
Exclusion criteria
Exclusion criteria: Patients with a history of neurological diseases such as hereditary or acquired neuropathies Patients with neuropathic pain due to conditions such as post-herpes neuralgia, uncontrolled diabetes with neuropathy, trigeminal neuralgia, spinal cord injury or other neurological diseases, known vitamin B12 deficiency, amyloidosis, neuromuscular diseases and connective tissue diseases Creatinine clearance less than 30 ml / min Severe liver failure History of allergy to lacosamide or duloxetine History of duloxetine or lacosamide use Evidence of severe systemic disease patients with epilepsy Drugs that interact with the study drugs including tricyclic antidepressants (TCAs), norepinephrine-specific serotonin reuptake inhibitors (SNRIs), and sodium channel blockers in the past three months Use of monoamine oxidase inhibitors (MAOIs) in the last fourteen days or simultaneously Drugs that interact with the study drugs including atazanavir, siponimod, carbamazepine, phenobarbital, phenytoin, amiodarone, sotalol, antiarrhythmic drugs that increase QT interval, including class IA and IC, beta-blockers and non-dihydropyridine calcium channel blockers, lidocaine, and mexiletine Pregnant or lactating women Dissatisfaction with participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of neuropathy based on FACT/GOG-Ntx. Timepoint: Measurement of severity of neuropathy based on FACT/GOG-Ntx at baseline and end of week 6 and end of week 12 of Lacosamide / placebo use. Method of measurement: Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity (FACT/GOG-Ntx).;The severity of neuropathy based on Neuropathy pain scale. Timepoint: Measurement of severity of neuropathy based on Neuropathy pain scale at baseline and end of week 6 and end of week 12 of Lacosamide/placebo use. Method of measurement: Using Neuropathy pain scale.;The severity of neuropathy based on CTCAE. Timepoint: Measurement of severity of neuropathy based on CTCAE at baseline and end of week 6 and end of week 12 of Lacosamide / placebo use. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.;Pain rate based on Numeric pain rating scale. Timepoint: Measurement of pain rate based on Numeric pain rating scale at baseline and end of week 6 and end of week 12 of Lacosamide/placebo use. Method of measurement: Using Numeric pain rating scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Averse effects. Timepoint: Record adverse effects at any time during the study. Method of measurement: With monitoring the patient.;Quality of life based on EORTC QLQ-C30. Timepoint: Measurement of Quality of life-based on EORTC QLQ-C30 at baseline and end of week 6 and end of week 12 of Lacosamide/placebo use. Method of measurement: Using EORTC Quality of Life Study Group version 3. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEbrahim Salehifar
Mazandaran University of Medical Sciences
Outcome results
None listed