Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced Peripheral Neuropathy

Mayo Clinic

Status

Enrolling

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Malignant Solid Neoplasm

Hematopoietic and Lymphoid System Neoplasm

Treatments

Other: Questionnaire Administration

Procedure: Spinal Cord Stimulation

Other: Quality-of-Life Assessment

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05411523

NCI-2022-02976 (Registry Identifier)

22-001218 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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