Can a new drug outperform standard care for chemotherapy nerve pain?

NCT ID NCT06711978

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests whether mirogabalin, a newer pain medication, can reduce nerve pain caused by chemotherapy better than the standard drug duloxetine. Cancer survivors with peripheral neuropathy in their feet will take one of the two drugs daily for four weeks. The study measures pain levels and quality of life to see which treatment offers more relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mirogabalin and duloxetine
What this could lead to
If mirogabalin proves more effective than duloxetine, it could offer a new, better-tolerated option for managing chemotherapy-induced nerve pain, improving quality of life for cancer survivors.
What could go wrong
This is a small, early-stage trial, and results may not apply to all patients. Both drugs can cause side effects, and mirogabalin may not show a clear advantage over the standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

66 people

The number who actually took part.

Started

Dec 2024

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Yangsan Pusan National University Hospital

    Yangsan, 50612, South Korea

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