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

Pusan National University Yangsan Hospital

Status

Not yet enrolling

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy

CIPN in Adjuvant Breast Cancer Patients

Duloxetine

Mirogabalin

CIPN

Treatments

Drug: Duloxetine

Drug: Mirogabalin

Study type

Interventional

Funder types

Other

Identifiers

NCT06711978

11-2024-072

Details and patient eligibility

About

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

Enrollment

66 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.