Chemotherapy-Induced Peripheral NeuropathyNCT05411523
Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced Peripheral Neuropathy
An observational study of Chemotherapy-Induced Peripheral Neuropathy and Hematopoietic and Lymphoid System Neoplasm, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Spinal Cord Stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to 15 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with CIPN.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Ryan S. D'Souza, MD
About this study
Official title: A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Spinal Cord Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Complete quality of life assessment
Questionnaire AdministrationOther
Complete questionnaires
Spinal Cord StimulationProcedure or surgery
Also called SCS
Receive spinal cord stimulation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months
Secondary outcomes (7)
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.
Measured: At 3 months and 12 months
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.
Measured: At baseline and 6 months
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.
Measured: At baseline and 6 months
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.
Measured: At baseline and 3, 6, and 12 months
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.
Measured: At baseline and 3, 6, and 12 months
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.
Measured: At baseline and 3, 6, and 12 months
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.
Measured: At baseline and 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start14 Apr 2022
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan S. D'Souza, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411523
- Sponsor's protocol ID
- 22-001218
- Other IDs
- NCI-2022-02976
- Status last verified
- Jul 2026
- First submitted
- 6 Jun 2022
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05411523
- Acronym / sponsor ID
- 22-001218
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (spinal cord stimulation, questionnaires) | – | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Spinal Cord StimulationPatients receiving spinal cord stimulation therapy complete questionnaires over 30 minutes at baseline and at 3, 6, and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with CIPN.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete quality of life assessment | Other | Observational (spinal cord stimulation, questionnaires) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (spinal cord stimulation, questionnaires) |
| Spinal Cord StimulationAlso: SCSReceive spinal cord stimulation therapy | Procedure or surgery | Observational (spinal cord stimulation, questionnaires) |
Primary outcome
Pain intensity
Time frame: At 6 months
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.
7 secondary outcomes
Pain intensity
Time frame: At 3 months and 12 months
Neuropathy assessment
Time frame: At baseline and 6 months
Neuropathic pain severity
Time frame: At baseline and 6 months
Perceived change/satisfaction
Time frame: At baseline and 3, 6, and 12 months
Health-related quality of life
Time frame: At baseline and 3, 6, and 12 months
Sleep issues
Time frame: At baseline and 3, 6, and 12 months
Adverse events
Time frame: At baseline and 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryan S. D'Souza, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-Induced Peripheral Neuropathy and Hematopoietic and Lymphoid System Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.