Botulinum toxin A to treat chemotherapy-related peripheral neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, placebo-controlled trial enrolling 40 breast cancer patients with chemotherapy-induced peripheral neuropathy to receive either intradermal IncobotulinumtoxinA (n=20) or saline placebo (n=20). Participants must have neuropathic pain beginning within six months of chemotherapy and a DN4 score >4, and several standard exclusions apply such as other causes of neuropathy, recent chemotherapy, pregnancy, and end-stage renal disease on hemodialysis. The study will monitor safety and pain outcomes following injections to determine whether INA provides clinically meaningful relief compared with placebo. The protocol is being run at Froedtert Hospital under the Medical College of Wisconsin sponsorship.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Been diagnosed with breast cancer and undergone treatment with taxane based chemotherapeutic agents. Patients with metastatic and non metastatic disease are eligible.
2. Have neuropathic pain with onset within 6 months of chemotherapy
3. Must score \>4 on DN4 scale, a scale with high specificity and sensitivity for differentiating neuropathic pain from somatic and nociceptive pain
4. Age \>18 years, male and/or female
5. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. End Stage Renal Disease patients on Hemodialysis
2. Female participants who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or intend to become pregnant within 6 months.
3. History of peripheral neuropathy attributed to any cause other than chemotherapy
4. Currently receiving chemotherapy, or having had received chemotherapy in the past 6 months
5. Prior treatment with Botulinum Toxin A for any indication within the past 6 months
6. Changes in neuropathic pain modulators within 1 month prior to enrollment or during the course of the trial. Participants who require rescue medications for breakthrough pain can be given so at the discretion of their provider.
7. Hypersensitivity reaction to INA injection
8. Distal muscle weakness and/or atrophy
9. Active infection at injection site

Where it's running

• Froedtert Hospital
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Study coordinator: Erin McGonigle, MD
• Email: emcgonigle@mcw.edu
• Phone: 414-955-1914

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.