Spinal Cord Stimulation to Treat Chemotherapy-Induced Peripheral Neuropathy
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-001218
NCT ID: NCT05411523
Sponsor Protocol Number: 22-001218
About this study
The purpose of this study is to understand pain outcomes in patients with cancer who have Chemotherapy-Induced Peripheral Neuropathy (CIPN).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult patients aged 18 to 70 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
Eligibility last updated 8/9/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available