Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| taVNS Intervention Cohort | Experimental | Participants in this group will receive a 2-week course of daily self-applied transcutaneous auricular vagus nerve stimulation (taVNS) for chronic chemotherapy induced peripheral neuropathy (CIPN). Participants will use a portable taVNS device at home once daily for 14 consecutive days, applying stimulation to the auricular vagus nerve according to standardized instructions provided by the study team. Each stimulation session will last approximately 60 minutes at monophasic pulses. The treatment stimulation intensity can be increased up to 5mA, but this will be adjusted for each participant to ensure it is below the pain threshold. |
|
| No intervention (Prospective Registry Cohort) | No Intervention | Participants in this group will not receive an intervention. This group consists of a prospective registry cohort of cancer survivors with prior taxane or platinum exposure who did not develop chronic chemotherapy induced peripheral neuropathy (CIPN). Participants will be enrolled into the registry for classification and observational comparison purposes only. No stimulation device is provided, and no active treatment or experimental procedure is administered during the 14-day registry period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate (taVNS Intervention Cohort) | 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. | Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3) |
| Retention Rate (Prospective Registry Cohort) | 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. | Baseline (Day 0 (T0) and Day 14 (T2) |
| Recruitment Rate (taVNS Intervention Cohort) | Recruitment rate will be calculated as the percentage of eligible participants who consent to participate in the study. | Baseline (Day 0 (T0), through end of enrollment period (anticipated within 6 months) |
| Acceptability (taVNS Intervention Cohort) | 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. | Baseline (Day 0 (T0) through Day 28 follow-up (T3) (approximately 6 weeks after baseline (T0) |
| Treatment Adherence (taVNS Intervention Cohort) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CIPN Symptoms Severity (EORTC QLQ-CIPN20) (taVNS Intervention Cohort) | 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. |
Not provided
Inclusion Criteria:
Chemotherapy-induced peripheral neuropathy (CIPN) group:
Registry Cohort:
Exclusion Criteria:
All participants:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard L Martinez, MSPH | Contact | 3052842359 | rxm1388@med.miami.edu | |
| Marlon L Wong, PT, PhD | Contact | 3052842670 | mwong2@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marlon L Marlon, PT, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami, Plumer Building | Recruiting | Coral Gables | Florida | 33146 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
|
| 14 days of intervention |
| Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3) |
| Change in Neuropathic Pain Intensity (Numeric Pain Rating Scale) (taVNS Intervention Cohort) | 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. | Baseline (Day 0 (T0), Day 7 (T1), Day 14 (T2), and Day 28 follow-up (T3) |
| Change in Serum Neurofilament Light Chain (NfL) | 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). | Baseline (Day 0 (T0), to Day 14 (T2) |
| Change in Serum Interleukin-1 Beta (IL-1β) | 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. | Baseline (Day 0 (T0) to Day 14 (T2) |
| Change in Serum Tumor Necrosis Factor-Alpha (TNF-α) | 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. | Baseline (Day 0 (T0) to Day 14 (T2) |
| Change in Serum Interleukin-6 (IL-6) | 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 . | Baseline (Day 0, (T0) to Day 14 (T2) |
| Change in SICI (neurophysiological measure of corticospinal excitability) | 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. | Baseline (Day 0 (T0) to Day 14 (T2) |
| Change in Heart rate variability (HRV, surrogate measure of autonomic balance) | 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). | Baseline (Day 0 (T0) to Day 14 (T2) |