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Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Primary Purpose

Peripheral Neuropathy Due to Chemotherapy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IncobotulinumtoxinA (Xeomin®, Merz) (INA)
Normal saline
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy Due to Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Froedtert HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IncobotulinumtoxinA

saline control

Arm Description

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).

Outcomes

Primary Outcome Measures

Improvement in pain from baseline at eight weeks as measured by the change in Neuropathic Pain Scale (NPS)
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

Improvement in pain from baseline as measured by the change in Neuropathic Pain Scale (NPS)
Change pain as measured by the NPS at additional time points: 2weeks, 4 weeks, 12 weeks, 6 months when compared to baseline scores.
Change in pain characteristics as measured by the change in each individual domain of Neuropathic Pain Scale (NPS)
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.
Change in quality of life as measured by the Neuropathic Pain Impact on Quality of Life (NePIQoL) score
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
Safety as measured by self reporting of incidence of treatment related adverse events
incidence of treatment related adverse events within each cohort

Full Information

First Posted
June 11, 2018
Last Updated
December 21, 2021
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT03571334
Brief Title
Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Official Title
Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Chemotherapy Induced Peripheral Neuropathy Chemotherapy induced peripheral neuropathy (CIPN) is a common adverse effect of cancer therapy, effecting over half of all patients who receive chemotherapy. CIPN typically manifests as a symmetrical, predominately sensory peripheral neuropathy, and is most common in taxanes, vinca-alkaloids, and/or platinum compounds. Taxanes are microtubule stabilizing agents and are effective in the treatment of many solid organ cancers, often used as first line therapy in the treatment of breast cancer. Taxanes cause peripheral neuropathy by injuring neurons, disrupting axonal transport, and causing wide spread macrophage activation both in the periphery as well as at the dorsal root ganglion (DRG) and microglial activation in the spinal cord. The incidence of CIPN is high following taxane administration, and often occurs before patients have completed the prescribed course. In severe cases it can lead to dose modifications and early treatment discontinuation, effecting overall survivorship. Additionally, it has been demonstrated to have a profound effect on quality of life, found to correlate with increased fatigue, malaise, increased psychological distress and a less sense of well being and satisfaction with life. Current treatment options are inadequate, with suboptimal treatment effect size and dose limiting adverse effects. Various neuroprotective regimens have been trialed, including co-administration of thiols, neurotrophic factors, antioxidants and vitamin E; however none of these approaches are consistently effective in reducing peripheral neuropathy. Botulinum Toxin (BoNT) Botulinum toxin (BoNT) is routinely used to treat a wide variety of disorders, traditionally by decreasing muscle activity through inhibiting the release of acetylcholine from the presynaptic nerve terminal. There has been a recent increase and growing body of evidence for the use of botulinum toxin in the treatment of neuropathic pain including postherpetic neuralgia, diabetic neuropathy, complex regional pain syndrome, trigeminal neuralgia, phantom limb pain, spinal cord injury-induced neuropathic pain, and central post-stroke pain. The mechanism by which BoNT effects neuropathic pain is independent than the effect of BoNT on muscle relaxation. There are several proposed mechanisms by which BoNT decreases neuropathic pain, all of which likely contributing to the antinociceptive effect. First, it has been shown that BoNT inhibits the release of sensory neurotransmitters such as substance P, calcitonin gene related peptide, and glutamate from nerve endings into the peripheral nerve terminal. This not only directly mediates pain, but has also been shown to result in decreased inflammation. In addition, recent work in the rat model suggests that the antinociceptive mechanism of BoNT may in part be due to a reduction of TRPV1 expression. TRPV1 is a well-known pain receptor which responds to mechanical, thermal and chemical stimuli, is heavily expressed on the DRG. BoNT has been shown to exhibit retrograde axonal transport from the periphery, so effects on the DRG and central nervous system cannot be overlooked and likely play a role in the mechanism. Recently, intradermal BoNT injections were found efficacious in treating diabetic peripheral neuropathy. Multiple studies have demonstrated a reduction in Visual Analog Scale (VAS) scores following intradermal BoNT injections on the dorsal aspect of the foot in diabetic patients with peripheral neuropathy. Similar to CIPN, diabetic neuropathy presents in a stocking-glove distribution with a predominant sensory neuropathy. BoNT has additionally been proven to be safe and efficacious when used specifically in a cohort of head, neck, and breast cancer patients who developed post surgical and post radiation neuropathic pain. In this study, affected patients underwent intradermal BoNT injections which resulted in improvement in VAS and clinical global impressions of change (CGI-C) scales. Together, this evidence suggests that intradermal BoNT injections are efficacious in the treatment of neuropathic pain, and is safe for use in the cancer population. If our hypothesis proves correct, we will demonstrate the efficacy of BoNT for treatment of CIPN, allowing for improved treatment options. An antihyperalgesic effect following intradermal BoNT injections was additionally observed in rats with Paclitaxel induced peripheral neuropathy, again suggesting that BoNT will be an effective treatment specifically in the CIPN patient population. In controlled studies, BoNT has consistently demonstrated a minimal adverse effect profile. Typically, adverse effects occur within one week of BoNT injection and are transient. As with any injection, localized pain, infection, bleeding may be associated. A metaanalysis of two studies using BoNT for the treatment of diabetic neuropathic pain concluded that there were no statistically significant adverse effects associated with BoNT treatment. Intradermal injections for the treatment of hyperhidrosis have FDA approval, and the most common adverse events associated (3-10% of adult patients) were injection site pain and hemorrhage. The specific aim of this study is to determine the efficacy of intradermal INA injections to reduce chemotherapy induced peripheral neuropathy in breast cancer patients who have undergone taxane-based chemotherapy. We hypothesize the treatment group who receives intradermal INA injections will have lower neuropathic pain scale (NPS) scores when compared to the control group who receives saline injections. 1.0 Objective The purpose of this study is to examine the change in pain via the neuropathic pain scale (NPS) in patients with chemotherapy induced peripheral neuropathy (CIPN) following intradermal IncobotulinumtoxinA ((Xeomin®, Merz) (INA) injections. 2.0 Experimental Design The study is a prospective, randomized, double-blinded placebo-controlled study. Forty study participants will be enrolled in this study and randomized into Control vs. Experimental groups Study participants will be screened in the breast cancer clinics of Drs. Chitambar and Kamaraju and other breast oncology providers at the Medical College of Wisconsin/Froedtert Hospital for symptoms of Grade II neuropathic pain (per Common Terminology Criteria for Adverse Events [CTCAE] v5.0) thought secondary to chemotherapy. Study participants interested in pursuing the study will be contacted by phone by a study team member and the protocols and consent form will be discussed. Interested participants will be scheduled for an appointment in the translational research unit (TRU) at the Medical College of Wisconsin. a. The adult TRU is located within Froedtert Hospital and is dedicated strictly to conducting human research. Facilities include basic medical equipment, fully staffed nursing support, 5 exam rooms and 3 procedure rooms. The study participant will have the opportunity to ask the investigator about any questions they may have. Following this, the consent form will be signed and a copy will be given to the patient. Study participants will then be issued the DN4 questionnaire, a clinician administered questionnaire that has a high level of sensitivity and specificity in discriminating neuropathic pain. A score ≥4 represents likely neuropathic pain. Study participants will then undergo nerve conduction velocity (NCV) exams to confirm diagnosis of sensory neuropathy. Exam will be administered by PM&R physician or resident. Study participants will complete baseline neuropathic pain scale (NPS) assessments Study participants will complete baseline Neuropathic Pain Impact on Quality of Life (NePIQoL) assessment Study participants will disclose and document current pain medication regimen. This will include scheduled and prn medications taken for treatment of chemotherapy induced peripheral neuropathy as well as scheduled and prn medications used for treatment of other nociceptive pain. Recruited participants will then be randomized to Experimental vs Control groups Study participants who meet inclusion criteria will then undergo intradermal injection of INA or placebo into the bilateral hands or feet, depending on the location of the neuropathic pain. The injecting physician, Dr. Erin McGonigle (PI)/Dr. Erin Beddows (Co-I) and the subject will be blinded to the contents of the injection. INA will be reconstituted with preservative-free normal saline to a dilution of 5mL:100 units Anatomical site of injections (hands vs feet) will be determined based on patient report of severity of pain and impact of pain on quality of life. 2% lidocaine jelly will be applied as a topical anesthetic for 3 minutes to site of injections Site of injections will then be thoroughly cleaned with antiseptic solution of 75% alcohol and allowed to dry Study participants undergoing intradermal injections of bilateral hands/feet will receive 50u INA (total volume 2.5mL) or equivalent volume normal saline injected into each limb, max 2 limbs per subject. INA or saline equivalent 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). 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). Injections will be performed intradermally using a 5/16-inch, 32-g needle 2.1 Study Duration The duration of this study will be 6 months following intervention. 2.2 Study Participants Responsibilities Study participants will need to attend one research-related clinic visit for NCS testing Study participants will need to attend one research-related clinic visit for injection o This may be the same visit as the NCS Study participants will be requested to answer a telephone and/or RedCap survey pending the participant's preference. 2.3 Study participants Forty study participants will be enrolled in this double blinded, randomized, controlled trial and they will be grouped by treatment method: Experimental vs. Control, as determined by a randomization table Study participants will be over 18 years of age, both genders, all ethnicities, and currently diagnosed with chemotherapy induced peripheral neuropathy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy Due to Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IncobotulinumtoxinA
Arm Type
Experimental
Arm Description
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).
Arm Title
saline control
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
IncobotulinumtoxinA (Xeomin®, Merz) (INA)
Other Intervention Name(s)
Xeomin® (Brand name)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
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 Measure Information:
Title
Improvement in pain from baseline at eight weeks as measured by the change in Neuropathic Pain Scale (NPS)
Description
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.
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Improvement in pain from baseline as measured by the change in Neuropathic Pain Scale (NPS)
Description
Change pain as measured by the NPS at additional time points: 2weeks, 4 weeks, 12 weeks, 6 months when compared to baseline scores.
Time Frame
baseline and 2 weeks, 4 weeks, 12 weeks, 6 months
Title
Change in pain characteristics as measured by the change in each individual domain of Neuropathic Pain Scale (NPS)
Description
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.
Time Frame
baseline and 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months
Title
Change in quality of life as measured by the Neuropathic Pain Impact on Quality of Life (NePIQoL) score
Description
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
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months post intervention
Title
Safety as measured by self reporting of incidence of treatment related adverse events
Description
incidence of treatment related adverse events within each cohort
Time Frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin McGonigle, MD
Phone
414-955-1914
Email
emcgonigle@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Meghann Sytsma, BS
Phone
414-955-1922
Email
mesytsma@mcw.edu
Facility Information:
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghann Sytsma
Phone
414-955-1922
Email
mesytsma@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy

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