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Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT03571334
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Erin McGonigle, Medical College of Wisconsin

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Due to Chemotherapy Drug: IncobotulinumtoxinA (Xeomin®, Merz) (INA) Drug: Normal saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Actual Study Start Date : July 8, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).

Drug: IncobotulinumtoxinA (Xeomin®, Merz) (INA)
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
Other Name: Xeomin® (Brand name)

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).

Drug: Normal saline
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




Primary Outcome Measures :
  1. Improvement in pain from baseline at eight weeks as measured by the change in Neuropathic Pain Scale (NPS) [ Time Frame: baseline and 8 weeks ]
    The primary outcome of this study will be the change pain as measured by the NPS at 8 weeks post intervention as compared to baseline NPS scores. The NPS is a validated scale that is used to classify patient's neuropathic pain. It includes assessment of global pain intensity and pain unpleasantness, two items addressing the location of the pain as deep or surface, and six items addressing the specific qualities of neuropathic such as sharp, hot, dull, cold, sensitivity, and itchy.


Secondary Outcome Measures :
  1. Improvement in pain from baseline as measured by the change in Neuropathic Pain Scale (NPS) [ Time Frame: baseline and 2 weeks, 4 weeks, 12 weeks, 6 months ]
    Change pain as measured by the NPS at additional time points: 2weeks, 4 weeks, 12 weeks, 6 months when compared to baseline scores.

  2. Change in pain characteristics as measured by the change in each individual domain of Neuropathic Pain Scale (NPS) [ Time Frame: baseline and 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months ]
    Change in the pain characteristics as measured by each NPS domain when compared to baseline at additional time points: 2weeks, 4 weeks, 8 weeks, 12 weeks, 6 months. Domains include: assessment of global pain intensity and pain unpleasantness, two items addressing the location of the pain as deep or surface, and six items addressing the specific qualities of neuropathic such as sharp, hot, dull, cold, sensitivity, and itchy.

  3. Change in quality of life as measured by the Neuropathic Pain Impact on Quality of Life (NePIQoL) score [ Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months post intervention ]
    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. The NePIQoL is a validated scale comprised of 42 items organized into 7 categories of questions affecting quality of life: symptoms, relationships, psychological, social activity, physical change, personal care, overall health and overall quality of life

  4. Safety as measured by self reporting of incidence of treatment related adverse events [ Time Frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months post intervention ]
    incidence of treatment related adverse events within each cohort



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571334


Contacts
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Contact: Erin Beddows, MD 616-446-9393 ebeddows@mcw.edu
Contact: Erin McGonigle, MD 414-955-1914 emcgonigle@mcw.edu

Locations
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United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Meghann Sytsma    414-955-1922    mesytsma@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Additional Information:
Publications:

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Responsible Party: Erin McGonigle, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03571334    
Other Study ID Numbers: ebeddows
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
incobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents