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

Launched by PUSAN NATIONAL UNIVERSITY YANGSAN HOSPITAL · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two medications, mirogabalin and duloxetine, to see which one works better in reducing pain caused by chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a common side effect for many cancer survivors, especially those treated with certain types of chemotherapy, leading to pain and discomfort in the feet. The study will involve participants taking either mirogabalin or duloxetine daily for four weeks and visiting a clinic every two weeks for check-ups.

To be eligible for this trial, you should be a cancer survivor aged 19 or older, experiencing pain in both feet that started within 12 weeks of chemotherapy. You should also have a certain level of pain intensity during the past week. Some pain medications can be used while in the study, but others need to be stopped for a week before starting. The trial is not yet recruiting participants, but it aims to find out which medication helps improve the quality of life for patients dealing with this painful condition.

Gender

ALL

Eligibility criteria

• 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.