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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorPusan National University Yangsan Hospital

About this trial

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

Eligibility criteria

Qualifiers

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.

No new analgesics are introduced.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Mirogabalin
  • Duloxetine

Treatment groups

66 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Yangsan Pusan National University Hospital Status unavailable 50612, MulgeumSouth Korea