- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06162403
Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Primary objective:
To assess Pain intensity (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of peripheral nerve stimulation (PNS).
Secondary objectives:
To assess changes in quantitative sensory testing (QST), gait testing, and skin punch biopsy to compare the integrity of Meissner's corpuscles (MC), pain disability using the Oswestry Disability Index (ODI), pain interference using the Brief Pain Inventory (BPI), and Patient Global Impression of Change (PGIC) in CIPN patients before and after use of PNS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Saba Javed, MD
- Phone Number: (713) 792-9530
- Email: sjaved@mdanderson.org
Study Locations
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Contact:
- Saba Javed, MD
- Phone Number: 713-792-9530
- Email: sjaved@mdanderson.org
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Principal Investigator:
- Saba Javed, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Pregnant participants
- Participants with conditions that conflict with the SPRINT PNS System Indications for Use, including Contraindications and Warnings.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peripheral Nerve Stimulation
Participants will be asked to have PNS leads inserted via a needle, which will provide a mild, stimulating electrical current to the effected nerves 24 hours a day for up to 60 days.
Participants will have study visits during and after this time.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and adverse events (AEs)
Time Frame: Through study completion; an average of 1 year.
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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Through study completion; an average of 1 year.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saba Javed, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0368
- NCI-2023-10303 (Other Identifier: NCI-2023-10303)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chemotherapy-induced Peripheral Neuropathy
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Academisch Medisch Centrum - Universiteit van Amsterdam...Leiden University Medical Center; Reinier de GraafRecruitingChemotherapy-induced Peripheral Neuropathy | CIPN - Chemotherapy-Induced Peripheral Neuropathy | Qutenza | DuloxetineNetherlands
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Arash Asher, MDVoxxLifeRecruitingNeuropathy | Chemotherapy-induced Peripheral Neuropathy | Neuropathy;PeripheralUnited States
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Odense University HospitalAarhus University Hospital; University of Southern Denmark; Sygehus LillebaeltRecruitingChemotherapy-induced Peripheral NeuropathyDenmark
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Donna Hammond, PhDActive, not recruitingChemotherapy-induced Peripheral NeuropathyUnited States
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University of Rochester NCORP Research BaseNational Cancer Institute (NCI)CompletedEffects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral NeuropathyChemotherapy-Induced Peripheral NeuropathyUnited States
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