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New treatment option for Peripheral Neuropathy Due to Chemotherapy
Official title Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy
ClinicalTrials.gov ID: NCT03571334
What this study is testing
What is IncobotulinumtoxinA (Xeomin®, Merz) (INA)?
IncobotulinumtoxinA (Xeomin®, Merz) (INA) is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for peripheral neuropathy due to chemotherapy.
Also referred to as Xeomin® (Brand name).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Been diagnosed with breast cancer and undergone treatment with taxane based chemotherapeutic agents. Patients with metastatic and non metastatic...
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility 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.
- 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...
- Hypersensitivity reaction to INA injection
- Distal muscle weakness and/or atrophy
- Active infection at injection site
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.