Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorM.D. Anderson Cancer Center

About this trial

To learn if peripheral nerve stimulation (PNS) can help to improve pain in participants with CIPN.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants diagnosed with chronic (≥90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds or ionizing irradiation) of the lower extremity, seen at Pain Management Center at MD Anderson Cancer Center

Participants reports baseline pain ≥ 4 (0-10 scale, NRS)

Participants between ages 18-85 years old

Participants who have completed chemotherapy within the previous year at the time of enrollment

Disqualifiers

Participants with cognitive dysfunction

Participants with recent history (<6 months) of drug or alcohol abuse

Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection

Participants with allergies to local anesthesia, steroids, or adhesives

Trial design

Design model

Single group

Treatments tested in this trial

  • Peripheral Nerve Stimulation

    Other intervention

    The leads are inserted through a needle. If needed, the study team may give participants anesthetic (for example, as a cream/gel on your skin and/or as an injection) to numb the area where the leads will be injected.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Peripheral Nerve StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and adverse events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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