RECRUITING

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

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Conditions

Chemotherapy-Induced Peripheral NeuropathyHematopoietic and Lymphoid System NeoplasmMalignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-14
Study Completion:2026-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05411523

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Average pain intensity \>= 5 on 11-point numeric rating scale (NRS) in the lower extremities at enrollment
  3. * Failed conventional medication management with at least two neuropathic pain medications
  4. * Have electrophysiological evidence of length-dependent peripheral neuropathy
  5. * 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
  6. * Have stable neurological status
  7. * Be on a stable analgesic regimen
  8. * Be an appropriate candidate for surgical procedures required in this study
  9. * Be able to read and understand English-written questionnaires and sign an informed consent form in English
  10. * Be willing and capable of giving informed consent
  11. * Be willing and able to complete study-related requirements, procedures, and visits
  1. * Patient refusal to be included in study
  2. * Presence of lower limb mononeuropathy
  3. * History of lower limb amputation or ulceration
  4. * Presence of another painful condition that is unrelated to CIPN and that is not intended to be treated in this study
  5. * Body mass index (BMI) \>= 40
  6. * Omeprazole (OME) \> 120 mg
  7. * 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)
  8. * Certain comorbidities: coagulation/bleeding disorders, diminished capacity from cardiac/pulmonary disease
  9. * Obtaining another interventional procedure unrelated to SCS to treat limb pain
  10. * Have ongoing metastatic malignant neoplasm or untreated local malignant neoplasm. Included patients must be deemed as in remission per discretion of treating oncologist
  11. * Have a life expectancy of less than one year
  12. * Have untreated addiction or dependency to medications, alcohol, or illicit drugs
  13. * Have active, disruptive, and/or unstable psychological or psychiatric disorder

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Ryan S D'Souza, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Ryan S D'Souza, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-14
Study Completion Date2026-04-15

Study Record Updates

Study Start Date2022-04-14
Study Completion Date2026-04-15

Terms related to this study

Additional Relevant MeSH Terms

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