NCT05411523 Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced Peripheral Neuropathy
| NCT ID | NCT05411523 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Chemotherapy-Induced Peripheral Neuropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-04-14 |
| Primary Completion | 2027-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2022-04-14 with a primary completion date of 2027-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study examines how spinal cord stimulation (SCS) affects pain level and quality of life in patients experiencing chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a nerve problem and one of the potential side effects of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. CIPN usually begins in the hands or feet and gets worse over time. SCS is a type of therapy that has proven to be effective in treating numerous non-malignant pain disorders including failed back surgery syndrome, refractory angina, limb ischemia, complex regional pain syndrome, and diabetic peripheral neuropathy. SCS may also be useful in patients with CIPN. This study evaluates how SCS affects pain and quality of life in patients undergoing spinal cord stimulation for CIPN.
Eligibility 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
Contact & Investigator
Ryan S. D'Souza, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT05411523 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy-Induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05411523 currently recruiting?
Yes, NCT05411523 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT05411523 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05411523 clinical trial?
NCT05411523 is sponsored by Mayo Clinic. The principal investigator is Ryan S. D'Souza, MD at Mayo Clinic in Rochester. The trial plans to enroll 20 participants.