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NCT03571334 · ClinicalTrials.gov registry record · Phase 2
Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy
A Phase 2 study, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT03571334 is a Phase 2 study that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 40 participants.
The verdict
NCT03571334, a Phase 2 study, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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 includ
Interventions
- DRUG Normal saline
- DRUG IncobotulinumtoxinA (Xeomin®, Merz) (INA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-07-08 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03571334
The ClinicalTrials.gov registry entry for NCT03571334 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT03571334 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03571334 about?
NCT03571334 is a clinical study titled "Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy". 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 modificatio...
What is the current status of trial NCT03571334?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-07-08. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT03571334?
The interventions under investigation include: Normal saline (DRUG), IncobotulinumtoxinA (Xeomin®, Merz) (INA) (DRUG).
Who is sponsoring clinical trial NCT03571334?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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