Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Peripheral Neuropathy Due to Chemotherapy
About this trial
This is an interventional treatment trial for Peripheral Neuropathy Due to Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Been diagnosed with breast cancer and undergone treatment with taxane based chemotherapeutic agents. Patients with metastatic and non metastatic disease are eligible.
- Have neuropathic pain with onset within 6 months of chemotherapy
- Must score >4 on DN4 scale, a scale with high specificity and sensitivity for differentiating neuropathic pain from somatic and nociceptive pain
- Age >18 years, male and/or female
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
- End Stage Renal Disease patients on Hemodialysis
- Female participants who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or intend to become pregnant within 6 months.
- History of peripheral neuropathy attributed to any cause other than chemotherapy
- Currently receiving chemotherapy, or having had received chemotherapy in the past 6 months
- Prior treatment with Botulinum Toxin A for any indication within the past 6 months
- 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.
- Hypersensitivity reaction to INA injection
- Distal muscle weakness and/or atrophy
- Active infection at injection site
Sites / Locations
- Froedtert HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
IncobotulinumtoxinA
saline control
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).
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).