Chemotherapy Induced Peripheral Neuropathy
Conditions
Keywords
vagus nerve stimulation, peripheral neuropathy, heart rate variability, transcranial magnetic stimulation
Brief summary
The purpose of this study is to determine the feasibility of using a portable device at home to self-administer transcutaneous auricular vagus nerve stimulation (taVNS). This handheld device has two small electrodes that are placed on specific areas of the outer ear. This device delivers a mild electrical stimulation to the vagus nerve through the ear. This study will explore how taVNS may affect symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Participants will be assigned to one of two cohorts based on the presence of chemotherapy-induced peripheral neuropathy (CIPN). Participants with CIPN will be placed in the intervention cohort (n=24) and will complete a 2-week trial of daily self-applied taVNS. Participants without CIPN will be placed in the registry cohort (n=12) and will complete study measurements without receiving the intervention. The registry cohort will not receive the taVNS intervention but will undergo identical physiological assessments at baseline and at a 2 week follow up to control for testing effects and biological variability.
Interventions
A portable taVNS Stimulator (Soterix Medical) will be used with flexible electrodes to administer taVNS near areas surrounding the ear. Each stimulation session will last approximately 60 minutes at monophasic pulses.
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This study utilizes a parallel-cohort design comprising two distinct components: Interventional Feasibility Cohort 1: (n=24): Feasibility interventional cohort of self-applied taVNS in cancer survivors with chronic CIPN. Prospective Registry Cohort 2: (n=12): An observational, non-interventional comparator cohort of cancer survivors with similar taxane/platinum exposure who did not develop chronic CIPN.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Chemotherapy-induced peripheral neuropathy (CIPN) group: * Age 18-80 years * Prior exposure to platinum or taxane chemotherapy * Glove/stocking dysesthesias ≥3 months that began after neurotoxic chemotherapy * Worst CIPN-related pain ≥4/10 over the last week Registry Cohort: * Age 18-80 years * Prior exposure to platinum or taxane chemotherapy * Denis any current neuropathic symptoms as described above.
Exclusion criteria
All participants: * Unstable cardiac disease/ Known arrhythmias * Head or neck cancer or metastases * Recent ear trauma or active dermatologic disease at the stimulation site * \<2 months since completion of cancer treatment or surgery * Metal implants in the head or neck (e.g., cochlear implant) * Implanted electronic devices (e.g., pacemaker) * Known allergy to tape/adhesives * History of seizure/epilepsy, intracranial pathology, or skull defect * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate (taVNS Intervention Cohort) | Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3) | Retention rate will be calculated as the percentage (%) of enrolled participants who complete all required study assessments by the end of their respective follow-up periods. Retention will be considered successful if ≥ 85% of enrolled participants complete the study. |
| Retention Rate (Prospective Registry Cohort) | Baseline (Day 0 (T0) and Day 14 (T2) | Retention rate will be calculated as the percentage (%) of enrolled participants who complete all required study assessments by the end of their respective follow-up periods. Retention will be considered successful if ≥ 85% of enrolled participants complete the study. |
| Recruitment Rate (taVNS Intervention Cohort) | Baseline (Day 0 (T0), through end of enrollment period (anticipated within 6 months) | Recruitment rate will be calculated as the percentage of eligible participants who consent to participate in the study. |
| Acceptability (taVNS Intervention Cohort) | Baseline (Day 0 (T0) through Day 28 follow-up (T3) (approximately 6 weeks after baseline (T0) | Acceptability will be measured as the percentage of participants reporting overall acceptable or satisfactory experiences with the intervention during exit interviews. Acceptability will be considered successful if ≥ 80% of participants provide favorable responses. |
| Treatment Adherence (taVNS Intervention Cohort) | 14 days of intervention | Treatment adherence will be assessed using the unique device-generated code associated with each taVNS session. Adherence will be considered successful if participants complete ≥ 80% of planned sessions as documented by device-logged session codes. Adherence will be calculated as: Number of completed session codes ÷ Number of programmed session codes) × 100 over the 14-day treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CIPN Symptoms Severity (EORTC QLQ-CIPN20) (taVNS Intervention Cohort) | Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3) | The EORTC quality of life questionnaire (CIPN20), will be used to assess CIPN symptoms over the past week. The CIPN20 is widely used in research and in clinical practice to assess pain CIPN symptoms using a 20-item validated questionnaire measuring sensory, motor, and autonomic neuropathy symptoms. Scores are transformed to 0-100 subscale scores according to the EORTC scoring manual, with higher scores indicating greater symptom severity. |
| Change in Neuropathic Pain Intensity (Numeric Pain Rating Scale) (taVNS Intervention Cohort) | Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3) | Neuropathic pain intensity will be assessed using the 0-10 Numeric Pain Rating Scale (NPRS). Participants will rate their worst pain over the past week on a scale from 0 (no pain) to 10 (worst imaginable pain). The NPRS is widely used in research and in clinical practice to assess nonpainful CIPN symptoms. |
| Change in Serum Neurofilament Light Chain (NfL) | Baseline (Day 0 (T0), to Day 14 (T2) | Change in serum neurofilament light chain (NfL) concentrations (picograms per milliliter \[pg/mL\]) will be calculated as the difference between values obtained at baseline (Day 0 \[T0\]) and Day 14 (T2). |
| Change in Serum Interleukin-1 Beta (IL-1β) | Baseline (Day 0 (T0) to Day 14 (T2) | Change in serum interleukin-1 beta (IL-1β) concentrations (picograms per milliliter \[pg/mL\]) will be calculated as the difference between values obtained at baseline (Day 0) and Day 14. |
| Change in Serum Tumor Necrosis Factor-Alpha (TNF-α) | Baseline (Day 0 (T0) to Day 14 (T2) | Change in serum tumor necrosis factor-alpha (TNF-α) concentrations (picograms per milliliter \[pg/mL\]) will be calculated as the difference between values obtained at baseline (Day 0) and Day 14. |
| Change in Serum Interleukin-6 (IL-6) | Baseline (Day 0, (T0) to Day 14 (T2) | Change in serum interleukin-6 (IL-6) concentrations (picograms per milliliter \[pg/mL\]) will be calculated as the difference between values obtained at baseline (Day 0) and Day 14 . |
| Change in SICI (neurophysiological measure of corticospinal excitability) | Baseline (Day 0 (T0) to Day 14 (T2) | Change in short-interval intracortical inhibition (SICI), will be calculated as the difference between values obtained at baseline (Day 0) and Day 14. SICI will be expressed as the ratio or percentage (%) of conditioned motor evoked potential (MEP) amplitude relative to unconditioned MEP amplitude. |
| Change in Heart rate variability (HRV, surrogate measure of autonomic balance) | Baseline (Day 0 (T0) to Day 14 (T2) | Change in heart rate variability (HRV), will be calculated as the difference between values obtained at baseline (Day 0) and Day 14 reported in milliseconds (ms). |
Countries
United States
Contacts
CONTACTRichard L Martinez, MSPH
CONTACTMarlon L Wong, PT, PhD
PRINCIPAL_INVESTIGATORMarlon L Marlon, PT, PhD
University of Miami
Outcome results
None listed