Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT03571334
Phase
PHASE2
Status
Recruiting
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Conditions

  • Peripheral Neuropathy Due to Chemotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IncobotulinumtoxinA (Xeomin®, Merz) (INA) — DRUG
    IncobotulinumtoxinA (Xeomin®, Merz) (INA) will be reconstituted with preservative-free normal saline to a dilution of 5mL:100 units. Study participants will receive 50u INA (total volume 2.5mL) injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.) Study participants will receive one series of injections during the trial. In the 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). In the feet, INA will be injected across the dorsal surface of the foot in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). Injections will be performed intradermally using a 5/16-inch, 32-g needle
  • Normal saline — DRUG
    Study participants will total volume 2.5mL of 0.9% Normal saline injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.) Study participants will receive one series of injections during the trial. In the hands, 0.9% Normal 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). In the feet, 0.9% Normal saline will be injected across the dorsal surface of the foot in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). Injections will be performed intradermally using a 5/16-inch, 32-g needle

Study Details

Chemotherapy induced peripheral neuropathy (CIPN) is a common side effect of taxanes and platinum derivative based chemotherapeutic agents, common in breast cancer treatment regimens. It can have a significant effect on both quality of life and treatment outcomes, often resulting in dose modifications and early treatment discontinuation. The use of IncobotulinumtoxinA (INA) ((Xeomin®, Merz) has recently been shown to be effective in the treatment of neuropathic pain via inhibiting the release of several neurotransmitters involved in pain signaling pathway. The purpose of this study is to examine the efficacy and safety of intradermal INA injections for treatment of CIPN in breast cancer patients. The study will recruit a total of 40 participants, randomly assigned to receive either INA (Experimental group, n=20) or saline placebo injections (Control group n=20). Potential participants who have received chemotherapy for breast cancer will be screened for the diagnosis of peripheral neuropathy. After obtaining informed consent, participants will be further screened with the DN4 questionnaire, a clinician administered questionnaire that has a high level of sensitivity and specificity in discriminating neuropathic pain. Those study participants who score ≥4 on this tool will undergo nerve conduction studies to confirm the presence of peripheral neuropathy. Recruited study participants will then be randomized to treatment or control groups; the treatment group will undergo intradermal injections of INA (100 Units INA, total volume 5ml), and the control groups will undergo placebo injection with preservative-free normal saline (equal volume, 5mL). Total injection volume will be divided evenly and injected intradermally into a total of 50 sites on either the feet or hands (25 sites per limb). The primary outcome will be the assessment of pain using the neuropathic pain scale (NPS) prior to intervention and at eight weeks post intervention. Secondary outcomes will include the change in NPS for each domain at additional time points: 2weeks, 4 weeks, 12 weeks, 6 months, the change in the Neuropathic Pain Impact on Quality of Life (NePIQoL) score at time points: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, and the incidence of treatment related adverse events within each cohort. Statistical analysis will be utilized to determine whether the injection of intradermal INA is effective in improving pain as measured by the NPS scales vs placebo. We hypothesize that the study participants treated with INA will have lower NPS scores as compared to placebo.

Key Dates

Start date
Jul 8, 2020
Status verified
Dec 2021
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IncobotulinumtoxinA
    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).
  • Placebo Comparator: saline control
    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).

Primary Outcome Measure

Improvement in pain from baseline at eight weeks as measured by the change in Neuropathic Pain Scale (NPS) [ Time Frame: baseline and 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert HospitalMilwaukeeWisconsin53226
Meghann Sytsma
[email protected]
414-955-1922

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By research site
Froedtert Hospital· Milwaukee, WI

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