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

Malignant Solid Neoplasm Clinical Trial

Official title:

A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411523
• Other study ID #: 22-001218
• Secondary ID: NCI-2022-02976
• Status: Recruiting
• Start date: April 14, 2022
• Est. completion date: April 15, 2026

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 15, 2026
• Est. primary completion date: April 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-Induced Peripheral Neuropathy
• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms
• Peripheral Nervous System Diseases

Intervention

Other:
• Quality-of-Life Assessment
Complete quality of life assessment
• Questionnaire Administration
Complete questionnaires

Procedure:
• Spinal Cord Stimulation
Receive spinal cord stimulation therapy

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain intensity	Percentage of patients who experience >= 50% improvement of pain intensity at 3 months and 12 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. SPSS software will be used for statistical analysis.	At 3 months and 12 months
Secondary	Neuropathy assessment	Assessed with Modified Toronto Clinical Neuropathic Pain Assessment performed by clinicians via a standardized neurological examination and scale. 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. SPSS software will be used for statistical analysis.	At baseline and 6 months
Secondary	Neuropathic pain severity	Assessed with Neuropathy Pain Scale, a comprehensive questionnaire with 11 items assessing components of neuropathic pain. 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. SPSS software will be used for statistical analysis.	At baseline and 6 months
Secondary	Perceived change/satisfaction	Patient Global Impression Scale reflects patient satisfaction and patient impression regarding the efficacy of the treatment or intervention. Graded on a 7-point scale. 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. SPSS software will be used for statistical analysis.	At baseline and 3, 6, and 12 months
Secondary	Health-related quality of life	Assessed using the European Quality of Life Five Dimension Five Level Scale Questionnaire, a validated scale that measures domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. 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. SPSS software will be used for statistical analysis.	At baseline and 3, 6, and 12 months
Secondary	Sleep issues	Assessed using the Medical Outcomes Study sleep scale, a 9-item questionnaire. Higher scores indicate poorer sleep quality. 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. SPSS software will be used for statistical analysis.	At baseline and 3, 6, and 12 months
Secondary	Adverse events	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. SPSS software will be used for statistical analysis.	At baseline and 3, 6, and 12 months