Botulinum toxin A to treat chemotherapy-related peripheral neuropathy
Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy
This trial will try small intradermal injections of IncobotulinumtoxinA (Xeomin) to see if they reduce neuropathic pain in breast cancer patients who developed neuropathy after taxane chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT03571334 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age >18) with breast cancer who developed neuropathic pain within six months after taxane-based chemotherapy and who score >4 on the DN4 neuropathic pain questionnaire are ideal candidates.
Not a fit: People with neuropathy from other causes, those currently receiving chemotherapy or treated within the past six months, pregnant or breastfeeding women, and patients on hemodialysis are unlikely to be eligible or to benefit in this protocol.
Why it matters
Potential benefit: If successful, intradermal IncobotulinumtoxinA could reduce neuropathic pain from chemotherapy and improve quality of life and functional ability for affected patients.
How similar studies have performed: Botulinum toxin A has shown benefit in some neuropathic pain conditions, but its use specifically for chemotherapy-induced peripheral neuropathy is relatively novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milwaukee, Wisconsin
- Froedtert Hospital — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Erin McGonigle, MD
- Email: emcgonigle@mcw.edu
- Phone: 414-955-1914
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.