Clinical trial NCT05411523: Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced Peripheral Neuropathy
Official title: A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with CIPN.

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.

Detailed description: PRIMARY OBJECTIVES:

I. To measure percentage of responders who had at least 50% reduction in lower extremity pain at 6 months.

II. To measure overall improvement in neurological assessment at 6 months. III. To measure secondary metrics including change in perceived global change/satisfaction, health-related quality of life, and sleep disturbance.

IV. To determine if there are any significant adverse events encountered with spinal cord stimulation (SCS) therapy for cancer-related pain.

OUTLINE:

Patients receiving spinal cord stimulation therapy complete questionnaires over 30 minutes at baseline and at 3, 6, and 12 months.

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

Primary outcomes:
measure: Pain intensity
timeFrame: At 6 months
Secondary outcomes:
measure: Pain intensity
timeFrame: At 3 months and 12 months
measure: Neuropathy assessment
timeFrame: At baseline and 6 months
measure: Neuropathic pain severity
timeFrame: At baseline and 6 months
measure: Perceived change/satisfaction
timeFrame: At baseline and 3, 6, and 12 months
measure: Health-related quality of life
timeFrame: At baseline and 3, 6, and 12 months
measure: Sleep issues
timeFrame: At baseline and 3, 6, and 12 months
measure: Adverse events
timeFrame: At baseline and 3, 6, and 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Ryan S. D'Souza, MD
role: PRINCIPAL_INVESTIGATOR
References: