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

NCT ID: NCT05411523

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-14
• Study Completion Date: 2027-04-15

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.

Conditions

Chemotherapy-Induced Peripheral Neuropathy; Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational (spinal cord stimulation, questionnaires)

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

Quality-of-Life Assessment

Intervention Type: OTHER

Complete quality of life assessment

Questionnaire Administration

Intervention Type: OTHER

Complete questionnaires

Spinal Cord Stimulation

Intervention Type: PROCEDURE

Receive spinal cord stimulation therapy

Interventions

Quality-of-Life Assessment

Complete quality of life assessment

Intervention Type: OTHER

Questionnaire Administration

Complete questionnaires

Intervention Type: OTHER

Spinal Cord Stimulation

Receive spinal cord stimulation therapy

Intervention Type: PROCEDURE

Other Intervention Names

Quality of Life Assessment; SCS

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan S. D'Souza, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Facility Contacts

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2022-02976

Identifier Type: REGISTRY

Identifier Source: secondary_id

22-001218

Identifier Type: -

Identifier Source: org_study_id