CIPN, CIPN - Chemotherapy-Induced Peripheral Neuropathy, CIPN in Adjuvant Breast Cancer Patients, Duloxetine, Mirogabalin
Conditions
Brief summary
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
Interventions
DRUGMirogabalin
Participants will receive Mirogabalin at a dose of twice daily for 4 weeks to manage CIPN pain.
DRUGDuloxetine
Participants will receive Duloxetine at a dose of once daily for 4 weeks to manage CIPN pain.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory-Short Form (BPI-SF) | Baseline, 2 weeks, and 4 weeks | The Brief Pain Inventory-Short Form (BPI-SF) assesses pain severity and pain interference. Pain severity is assessed using four items and pain interference using seven items. Each item is rated from 0 to 10. The pain severity and pain interference scores each range from 0 to 10, with higher scores indicating greater pain severity or greater pain-related interference and therefore a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NCI-CTCAE v5.0 | Baseline, 2 weeks, and 4 weeks | Chemotherapy-induced peripheral neuropathy (CIPN) severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0. Severity is graded from Grade 1 to Grade 5, with higher grades indicating greater severity; Grade 5 represents death related to the adverse event. |
| EORTC-QLQ-CIPN20 | Baseline, 2 weeks, and 4 weeks | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item module (EORTC QLQ-CIPN20) assesses sensory, motor, and autonomic symptoms associated with chemotherapy-induced peripheral neuropathy. Each item is rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). Scale scores are linearly transformed to a range of 0 to 100, with higher scores indicating greater neuropathic symptom burden and a worse outcome. |
| EORTC QLQ-C30 | Baseline and 4 weeks | Most items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much), while the two global health status/quality-of-life items are rated on a 7-point scale. All scale scores are linearly transformed to a range of 0 to 100. Higher scores on the functional and global health status/quality-of-life scales indicate better functioning or quality of life, whereas higher scores on the symptom scales indicate greater symptom severity and a worse outcome. |
| Korean Neuropathic Pain Questionnaire (KNPQ) | Baseline, 2 weeks, and 4 weeks | The Korean Neuropathic Pain Questionnaire (KNPQ) consists of 25 items assessing various characteristics of neuropathic pain. Twenty-two items are scored on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (the most severe pain imaginable) and are summed to calculate the total score, ranging from 0 to 220. Higher scores indicate a greater neuropathic pain symptom burden. |
| sural SNAP amplitude | At Baseline | — |
| peroneal cMAP amplitude | At Baseline | — |
| Medication compliance & ADRs | 2 weeks and 4 weeks | — |
Countries
South Korea
Outcome results
None listed