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Neurotoxin

Botulinum Toxin A for Peripheral Neuropathy

Phase 2

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have been diagnosed with breast cancer and undergone treatment with taxane-based chemotherapeutic agents, including those with metastatic and non-metastatic disease

Be older than 18 years old

Must not have

History of peripheral neuropathy attributed to any cause other than chemotherapy

Female participants who are pregnant (positive urine pregnancy test), breastfeeding, or intend to become pregnant within 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months

Summary

This trial is examining whether a toxin commonly used to treat muscle spasms can also help relieve nerve pain caused by chemotherapy.

Who is the study for?

This trial is for breast cancer patients who have undergone taxane-based chemotherapy and are experiencing neuropathic pain within 6 months of treatment. Participants must be adults over 18, score >4 on the DN4 scale for neuropathic pain, and able to consent. Excluded are those with end-stage renal disease, pregnant or breastfeeding women, prior peripheral neuropathy causes other than chemotherapy, recent Botulinum Toxin A treatment or changes in pain medication.

What is being tested?

The study tests if IncobotulinumtoxinA (INA) injections can relieve chemotherapy-induced peripheral neuropathy (CIPN) better than saline placebo. Forty participants will be randomly assigned to receive either INA or saline injections into hands/feet sites. Pain levels will be measured using the Neuropathic Pain Scale before and after eight weeks of intervention.

What are the potential side effects?

Possible side effects include hypersensitivity reactions to INA injection, muscle weakness or atrophy where injected, infection at the injection site, and general discomfort from intradermal injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have breast cancer and have been treated with taxane-based chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have nerve damage not caused by chemotherapy.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I am currently on chemotherapy or finished it within the last 6 months.

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I am on hemodialysis for end-stage kidney disease.

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I have weakness or muscle loss in my hands or feet.

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I have an infection where I would get the injection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in pain characteristics as measured by the change in each individual domain of Neuropathic Pain Scale (NPS)

Change in quality of life as measured by the Neuropathic Pain Impact on Quality of Life (NePIQoL) score

Improvement in pain from baseline as measured by the change in Neuropathic Pain Scale (NPS)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IncobotulinumtoxinAExperimental Treatment1 Intervention

IncobotulinumtoxinA (Xeomin®, Merz) (INA) will be reconstituted with preservative-free normal saline to a dilution of 5mL:100 units. Study participants in this arm will receive 50u INA (total volume 2.5mL) injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.) Hands: INA will be injected across the palmar surface of the digits in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). Feet: INA will be injected across the dorsal surface of the feet also in a grid like pattern covering a total of 25 sites per limb (0.1mL/site).

Group II: saline controlPlacebo Group1 Intervention

Study participants in this arm will 2.5mL normal saline injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.) Hands: saline will be injected across the palmar surface of the digits in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). Feet: Saline will be injected across the dorsal surface of the feet also in a grid like pattern covering a total of 25 sites per limb (0.1mL/site).

0 / 7Eligibility criteria met