Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID03571334

Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy in Breast Cancer Patients

Led by Medical College of Wisconsin · Updated on 2021-12-23

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of intradermal IncobotulinumtoxinA (INA) injections to treat chemotherapy induced peripheral neuropathy (CIPN) in breast cancer patients. CIPN is a common side effect of taxane and platinum-based chemotherapy that causes nerve pain and can affect quality of life and treatment continuation. The study aims to compare the pain relief from INA injections to placebo saline injections in patients who have developed neuropathic pain after chemotherapy. The study involves 40 breast cancer patients with CIPN confirmed by nerve conduction studies and neuropathic pain scale scores. Participants will be randomly assigned to receive either intradermal INA injections or saline placebo injections in the hands or feet where pain is reported. The treatment consists of 50 units of INA or equivalent saline volume injected across 50 sites per participant (25 per limb) using a fine needle. The injections are given once, and the study follows patients for 6 months after intervention. Participants will have baseline and follow-up assessments including neuropathic pain scale (NPS) and quality of life questionnaires at 2, 4, 8, 12 weeks, and 6 months post-injection. Nerve conduction studies will confirm neuropathy before treatment. The study will monitor pain changes, quality of life impact, and any treatment-related side effects. Participants will attend clinic visits for testing and injection and may complete surveys by phone or online during follow-up. The primary outcome is pain improvement at 8 weeks measured by NPS scores.

CONDITIONS

Brief Title

Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with breast cancer and treated with taxane-based chemotherapy (metastatic or non-metastatic)
  • Neuropathic pain onset within 6 months of chemotherapy
  • Score greater than 4 on DN4 neuropathic pain questionnaire
  • Age 18 years or older, male or female
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • End Stage Renal Disease patients on hemodialysis
  • Pregnant or breastfeeding women or intending to become pregnant within 6 months
  • History of peripheral neuropathy from causes other than chemotherapy
  • Currently receiving chemotherapy or received it within the past 6 months
  • Botulinum Toxin A treatment within the past 6 months
  • Changes in neuropathic pain medications within 1 month before or during the trial
  • Hypersensitivity to INA injection
  • Distal muscle weakness or atrophy
  • Active infection at the injection site

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 to 2 visits for eligibility assessment including questionnaires and nerve conduction studies

Treatment

Duration - Single day

Participants receive one series of intradermal injections of either IncobotulinumtoxinA or placebo into the bilateral hands or feet depending on pain location.

1 visit for injection

Follow-up

Duration - 6 months

Participants are monitored for changes in neuropathic pain and quality of life over 6 months following the injection, including safety assessments.

Follow-up assessments at 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months post injection via telephone or survey

Trial Site Locations

Total: 1 location

1

Froedtert Hospital

Milwaukee, Wisconsin, United States, 53226

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Research Team

E

Erin McGonigle, MD

M

Meghann Sytsma, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4).

Didier Bouhassira, Nadine Attal, Haiel Alchaar...

https://pubmed.ncbi.nlm.nih.gov/15733628

Different antinociceptive effects of botulinum toxin type A in inflammatory and peripheral polyneuropathic rat models.

Christine Favre-Guilmard, Michel Auguet, Pierre-Etienne Chabrier

https://pubmed.ncbi.nlm.nih.gov/19576881

Relationships Among Pain Quality, Pain Impact, and Overall Improvement in Patients with Postherpetic Neuralgia Treated with Gastroretentive Gabapentin.

Roy Freeman, Mark S Wallace, Michael Sweeney...

https://pubmed.ncbi.nlm.nih.gov/26115203