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

Not Applicable

Not yet recruiting

• Conditions: CIPN; CIPN - Chemotherapy-Induced Peripheral Neuropathy; CIPN in Adjuvant Breast Cancer Patients; Duloxetine; Mirogabalin
• Interventions: Drug: Duloxetine; Drug: Mirogabalin

• Registration Number: NCT06711978
• Lead Sponsor: Pusan National University Yangsan Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study Start: 2024-12-01
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirogabalin Group	Duloxetine	-
Duloxetine Group	Mirogabalin	-

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory-Short Form (BPI-SF)	From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Name	Time	Method
NCI-CTCAE v5.0	From enrollment to the end of treatment at 4 weeks.
EORTC-QLQ-CIPN20	From enrollment to the end of treatment at 4 weeks.
EORTC QLQ-C30	From enrollment to the end of treatment at 4 weeks.
Korean neuropathic pain questionnaire neuropathic pain questionnaire(KPNQ)	From enrollment to the end of treatment at 4 weeks.
sural SNAP amplitude	At Baseline
peroneal cMAP amplitude	At Baseline
Medication compliance & ADRs	From enrollment to the end of treatment at 4 weeks

Trial Locations

Locations (1)

Yangsan Pusan National University Hospital; 🇰🇷 Mulgeum, Korea, Republic of