Pilot Study for the Use of Spinal Cord Stimulation to Alleviate Pain from Chemotherapy Induced Peripheral Neuropathy Due to Taxane or Platinum Based Agents

University of Maryland St. Joseph Medical Center0 sites10 target enrollmentSeptember 15, 2024

ConditionsChemotherapy-induced Peripheral Neuropathy

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Chemotherapy-induced Peripheral Neuropathy
Sponsor: University of Maryland St. Joseph Medical Center
Enrollment: 10
Primary Endpoint: -- Measure response of CIPN pain to HF10 treatment using the numeric scale of pain (NRS) at SCS trial for all subjects and at 3, 6 and 12 months after implant for subjects who qualify for permanent implant.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord will be a safe and effective treatment for CIPN, reducing pain in the lower extremities by at least 50%.

Registry

clinicaltrials.gov

Start Date

September 15, 2024

End Date

November 15, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Maryland St. Joseph Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•CIPN as diagnosed by Oncology and/or neurology
•Receipt of a platinum-based or taxane chemotherapy prior to development of CIPN
•Pain severity greater than 4 out of 10 on a numeric rating scale of pain
•Pain chronicity greater than 6 months after the cessation of chemotherapy
•Failure of medical therapy, which must have included duloxetine
•Age 18 or greater

Exclusion Criteria

•Platelet count less than 100k/mm3
•Spinal anatomy precluding placement of the SCS leads between T6 and T11
•Active infection
•Estimated Lifespan less than 1 year
•Receipt of vincristine, thalidomide, bortezomib, or eribulin within the prior 12 months

Outcomes

Primary Outcomes

-- Measure response of CIPN pain to HF10 treatment using the numeric scale of pain (NRS) at SCS trial for all subjects and at 3, 6 and 12 months after implant for subjects who qualify for permanent implant.

Time Frame: 1 year

Secondary Outcomes

- - Neuropathy symptoms will be quantified using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (CIPN20). CIPN20 is a 20-item patient questionnaire with items scored 1 to 4.(1 year)
- Pain interference in daily life will be quantified via the brief pain inventory (BPI).(1 year)
- Neuropathy findings will be quantified with the modified Toronto clinical neuropathy score (mTCNS).(1 year)
- The subject's impression of SCS efficacy will be measured using the patient global impression of change (PGIC).(1 year)
- Health related quality of life will be assessed using the EuroQOL5D-5L questionnaire.(1 year)
- Any treatment related adverse events observed during the trial will be documented using the Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0.(1 year)