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

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

To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN).

There will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (CIPN).

Participants will:

• Take drug duloxetine or a mirogabalin every day for 4 weeks.
• Visit the clinic once every 2 weeks for checkups and tests

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:

  1. No new analgesics are introduced.
  2. Current analgesics are not discontinued.
  3. 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.