Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Status:
Recruiting
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Medical College of Wisconsin
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA