Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
IncobotulinumtoxinA (Xeomin®, Merz) (INA)
DrugIncobotulinumtoxinA (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
DrugStudy 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: IncobotulinumtoxinAExperimental treatment 1 intervention
Group B: saline controlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline and 8 weeksSecondary outcomes
1
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.
Time frame
baseline and 2 weeks, 4 weeks, 12 weeks, 6 months2
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.
Time frame
baseline and 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months3
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
Time frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months post intervention4
Safety as measured by self reporting of incidence of treatment related adverse events
incidence of treatment related adverse events within each cohort
Time frame
2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months post interventionSponsors and contacts
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Source ClinicalTrials.gov