Chemotherapy-induced neuropathic pain in breast cancer patients without metastasis Breast neoplasms, Chemotherapy-induced neuropathy, Pain, Neuropathic
Conditions
Interventions
Mirogabalin administered orally at a dose of 5 mg twice daily for 1 week, followed by titration to 10 mg twice daily for 2 weeks, in combination with an oral placebo once daily at bedtime.,Mirogabalin
Placebo Comparator Drug,Active Comparator Drug
Sponsors
Cardiac Electrophysiology Research and Training Center (CERT)
Research grant from the Faculty of Dentistry
Eligibility
Sex/Gender
Female
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Female patients aged more than 20 years old 2) Diagnosed with breast cancer and will receive taxane-based chemotherapy 3) Given informed consent 4) Ability to communicate and understand Thai language
Exclusion criteria
Exclusion criteria: 1) Patients who have preexisting peripheral neuropathy such as diabetic neuropathy, uremic neuropathy, vitamin B1 deficiency, vitamin B12 deficiency, idiopathic peripheral neuropathy, post-herpetic neuralgia, and HIV-associated neuropathy 2) Patients receiving concurrent neurotoxic medications, including antiretroviral drugs (stavudine, zidovudine), immunosuppressants (tacrolimus, cyclosporine), antimicrobial agents (metronidazole, linezolid, isoniazid), phenytoin, amiodarone, thalidomide, and lenalidomide 3) Patients with metastatic cancer 4) Patients with a history of breast cancer recurrence or prior chemotherapeutic treatment 5) Patients currently receiving melatonin or mirogabalin 6) Allergy or have contraindications to melatonin or mirogabalin 7) Life expectancy less than 1 year 8) Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score Baseline, at neuropathic pain onset, and 21 days post-intervention Numerical rating scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence At neuropathic pain onset European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy,Anxiety and depression Baseline, at neuropathic pain onset, and 21 days post-intervention Hospital anxiety and depression scale (HADS) Thai version,Metabolomics Baseline, at neuropathic pain onset, and 21 days post-intervention Mass spectrometry,Mitochondria functions Baseline, at neuropathic pain onset, and 21 days post-intervention Functional mitochondrial assays,Inflammatory markers Baseline, at neuropathic pain onset, and 21 days post-intervention Real-time quantitative reverse transcription polymerase chain reaction | — |
Countries
Thailand
Contacts
Public ContactPassakorn Sawaddiruk
Faculty of medicine, Chiangmai University
Outcome results
None listed