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

November 26, 2024 updated by: Pusan National University Yangsan Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mirogabalin Group
Drug: Duloxetine
Participants will receive Duloxetine at a dose of once daily for 4 weeks to manage CIPN pain.
Active Comparator: Duloxetine Group
Drug: Mirogabalin
Participants will receive Mirogabalin at a dose of twice daily for 4 weeks to manage CIPN pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brief Pain Inventory-Short Form (BPI-SF)
Time Frame: From enrollment to the end of treatment at 4 weeks
From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Estimated)

December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-2024-072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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