Botulinum Toxin A for Chemotherapy-Induced Peripheral Neuropathy

This study is looking at whether IncobotulinumtoxinA (Xeomin®), a type of botulinum toxin, can help reduce pain from chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a common side effect of certain chemotherapy drugs, like those used for breast cancer, and can cause pain and discomfort. Researchers believe IncobotulinumtoxinA may work by blocking pain signals. You might be able to join if you are an adult with breast cancer who had taxane-based chemotherapy, developed neuropathic pain within six months of treatment, and score above 4 on a specific pain scale (DN4). The study will measure if your pain improves after eight weeks. The current status of this study is unclear, and it plans to enroll 40 participants.

Study design
This interventional study plans to enroll 40 participants. It compares IncobotulinumtoxinA injections to normal saline injections.
What's involved
Participants will receive one series of injections into either their hands or feet. Pain levels will be measured at the start of the study and again at eight weeks.
Compensation
Not stated in the trial record.
Follow-up
Pain improvement will be measured at eight weeks after the injections.

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NCT03571334

Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Recruiting
PHASE2Ages 18+InterventionalTreatment
Medical College of Wisconsin
~40 participants
Updated 2021-12-23 on ClinicalTrials.gov
What's tested:IncobotulinumtoxinA (Xeomin®, Merz) (INA)Normal saline

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement in pain from baseline at eight weeks as measured by the change in Neuropathic Pain Scale (NPS)
Measured over baseline and 8 weeks
Peripheral Neuropathy Due to Chemotherapy
1 sites across 1 states
Wisconsin1

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  • Improvement in pain from baseline at eight weeks as measured by the change in Neuropathic Pain Scale (NPS)baseline and 8 weeks

    The primary outcome of this study will be the change pain as measured by the NPS at 8 weeks post intervention as compared to baseline NPS scores. The NPS is a validated scale that is used to classify patient's neuropathic pain. It includes assessment of global pain intensity and pain unpleasantness, two items addressing the location of the pain as deep or surface, and six items addressing the specific qualities of neuropathic such as sharp, hot, dull, cold, sensitivity, and itchy.