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

NCT05411523 | Recruiting

• 2 other identifiers: 22-001218NCI-2022-02976
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Percentage of patients who experience \>= 50% improvement of pain intensity on numeric rating scale score at 6 months compared to baseline. Paired t-test test will be carried out to compare questionnaire scores between each follow-up time point and baseline. All p-values will be reported as two-sided. Statistical Packages for Social Sciences (SPSS) software will be used for statistical analysis.

  At 6 months

Secondary Outcomes (7)

• Pain intensity

  At 3 months and 12 months

• Neuropathy assessment

  At baseline and 6 months

• Neuropathic pain severity

  At baseline and 6 months

• Perceived change/satisfaction

  At baseline and 3, 6, and 12 months

• Health-related quality of life

  At baseline and 3, 6, and 12 months

Study Arms (1)

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.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Spinal Cord Stimulation

Interventions

Quality-of-Life Assessment OTHER

Complete quality of life assessment

Also known as: Quality of Life Assessment

Observational (spinal cord stimulation, questionnaires)

Questionnaire Administration OTHER

Complete questionnaires

Observational (spinal cord stimulation, questionnaires)

Spinal Cord Stimulation PROCEDURE

Receive spinal cord stimulation therapy

Also known as: SCS

Observational (spinal cord stimulation, questionnaires)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with CIPN.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Spinal Cord Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ryan S. D'Souza, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: April 14, 2022
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)