Effect of spinal cord stimulation on pain and quality of life in chemotherapy-induced peripheral neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.