Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors

Inclusion criteria

• Cancer survivors aged 19 years or older.
• Peripheral, symmetrical pain in both feet occurring within 12 weeks of initiating chemotherapy with taxane or platinum agents (or their combination).
• Patients experiencing at least grade 2 peripheral neuropathy as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with an average pain intensity of 4 or higher on the Numerical Rating Scale (NRS) during the past week, following the completion of chemotherapy.
• Concurrent use of selected analgesics (acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs]) is permitted if the following conditions are met:

• No new analgesics are introduced.
• Current analgesics are not discontinued.
• The total weekly 24-hour dose of analgesics does not vary by more than 10% during the 2 weeks prior to enrollment.
• Ongoing treatment for peripheral neuropathy or neuropathic pain must be discontinued at least 7 days before randomization

Exclusion criteria

• Patients with a prior diagnosis of peripheral neuropathy due to diabetes, trauma, alcohol abuse, compression, or other causes, or those with a previously diagnosed central nervous system disorder. (Patients with pre-existing diabetes or thyroid disease who had no symptoms of peripheral neuropathy, such as numbness or tingling in the hands or feet, before chemotherapy may be included.)
• Patients with significant psychiatric disorders, such as severe depression, bipolar disorder, or suicidal ideation.
• Pregnant or breastfeeding patients.
• Patients with a history of prior treatment with other neurotoxic chemotherapeutic agents.
• Patients with renal impairment (creatinine clearance < 30 mL/min) or hepatic dysfunction.
• Patients with planned surgical procedures within 4 weeks of enrollment.