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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-10303 | Other Identifier | NCI-2023-10303 |
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To learn if peripheral nerve stimulation (PNS) can help to improve pain in participants with CIPN.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral Nerve Stimulation | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral Nerve Stimulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion; an average of 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saba Javed, MD | Contact | (713) 792-9530 | sjaved@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Saba Javed, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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