Effect of spinal cord stimulation on pain and quality of life in chemotherapy-induced peripheral neuropathy
A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
This study is testing if spinal cord stimulation can help reduce pain and improve quality of life for people dealing with nerve pain from chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05411523 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of spinal cord stimulation (SCS) on pain levels and quality of life in patients suffering from chemotherapy-induced peripheral neuropathy (CIPN). The study aims to measure the percentage of patients who experience at least a 50% reduction in lower extremity pain after six months of SCS therapy. Additionally, it evaluates overall neurological improvement, health-related quality of life, and any adverse events associated with the treatment. Participants will complete questionnaires at baseline and at 3, 6, and 12 months to assess these outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with clinically diagnosed CIPN for more than six months and significant pain despite conventional medication.
Not a fit: Patients who have not undergone a successful trial of spinal cord stimulation or those with less severe pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for managing pain and improving quality of life in patients with CIPN.
How similar studies have performed: Other studies have shown positive outcomes with spinal cord stimulation for various pain conditions, suggesting potential success in this novel application for CIPN.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients greater than or equal to 18 years of age who have been clinically diagnosed with CIPN for greater than six months after stopping chemotherapy * Average pain intensity \>= 5 on 11-point numeric rating scale (NRS) in the lower extremities at enrollment * Failed conventional medication management with at least two neuropathic pain medications * Have electrophysiological evidence of length-dependent peripheral neuropathy * Underwent a 10-kHz spinal cord stimulator trial for a primary indication of CIPN and reported a successful trial of at least 75% reduction in pain intensity * Have stable neurological status * Be on a stable analgesic regimen * Be an appropriate candidate for surgical procedures required in this study * Be able to read and understand English-written questionnaires and sign an informed consent form in English * Be willing and capable of giving informed consent * Be willing and able to complete study-related requirements, procedures, and visits Exclusion Criteria: * Patient refusal to be included in study * Presence of lower limb mononeuropathy * History of lower limb amputation or ulceration * Presence of another painful condition that is unrelated to CIPN and that is not intended to be treated in this study * Body mass index (BMI) \>= 40 * Omeprazole (OME) \> 120 mg * Progressive neurological disease (multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, complex regional pain syndrome, acute herniating disc, severe spinal stenosis) * Certain comorbidities: coagulation/bleeding disorders, diminished capacity from cardiac/pulmonary disease * Obtaining another interventional procedure unrelated to SCS to treat limb pain * Have ongoing metastatic malignant neoplasm or untreated local malignant neoplasm. Included patients must be deemed as in remission per discretion of treating oncologist * Have a life expectancy of less than one year * Have untreated addiction or dependency to medications, alcohol, or illicit drugs * Have active, disruptive, and/or unstable psychological or psychiatric disorder
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ryan S. D'Souza, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.