Can a new drug outperform standard care for chemotherapy nerve pain?
NCT ID NCT06711978
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for CIPN are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Retraining the senses to fight chemotherapy nerve damage
- Retraining the senses to fight chemotherapy nerve damage
- Chilling out Chemo's side effects: could cold therapy shield nerves?
- Zapping the brain to ease chemo nerve pain: a new hope for breast cancer survivors
- New pill aims to ease chemo nerve damage in early trial
- Could a daily 5-Minute mask soothe nerve pain?