The Effect of Low Frequency Soundwave Stimulation on Chemotherapy Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess the efficacy of SensoniQ® Treatment Station in preventing or reducing chemotherapy induced peripheral neuropathy (CIPN) in patients receiving frontline carboplatin and paclitaxel chemotherapy for a gynecologic malignancy. This study will also assess the improvement of CIPN in patients who have previously received carboplatin and paclitaxel therapy with persistent Grade 2 or worse neuropathy. The main questions this clinical trial aims to answer are: To investigate the efficacy of SensoniQ® Treatment Station on the prevention or reduction of CIPN in gynecologic oncology patients receiving front line carboplatin and paclitaxel. To investigate the efficacy of SensoniQ® Treatment Station on the improvement of existing CIPN in patients who previously received chemotherapy with carboplatin and paclitaxel for a gynecologic malignancy

Detailed Description
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Chemotherapy induced neuropathy (CIPN) is a common side effect in patients undergoing treatment for gynecologic malignancies. The most common treatment is a combination of paclitaxel and carboplatin. A previous analysis of these patients show that 71% experience chemo induced peripheral with neuropathy with 30% experiencing Grade 2 and 32% experiencing Grade 3. There is currently no intervention to prevent CIPN and only one medication, duloxetine, is recommended as treatment based on ASCO guidelines. The SensoniQ® Treatment Station is a chemotherapy chair with multiple transducers that release low- frequency sound waves to different points on the body in a preset frequency, distribution and time during a chemotherapy infusion. Previous investigational studies using SensoniQ® Treatment during chemotherapy infusion showed a reduction in neuropathy without any additional side effects or complications. This study seeks to show patient response measured by questionnaires to SensoniQ® Treatment and correlate with neurologic test findings to show reduced CIPN in patients undergoing frontline chemotherapy with carboplatin and paclitaxel as well as improvement in patients with existing CIPN. This treatment has the potential to change recommendations for prevention of CIPN and improve adherence to treatment and quality of life.

Official Title
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The Effect of Low Frequency Soundwave Stimulation on Chemotherapy Induced Peripheral Neuropathy

Conditions
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Gynecologic Cancer, Neuropathy;Peripheral

Intervention / Treatment
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* Device: SensoniQ Treatment Station


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all the following inclusion criteria to be eligible for inclusion in the study: Patients must be age 18 or older. Histologically confirmed gynecologic malignancy. Eastern Cooperative Oncology Group performance status of 0 to 2. Be willing and able to participate in all required evaluations for the protocol Speak, read, and understand English Cohort A patients must have: Carboplatin and paclitaxel prescribed as first line treatment Cohort B patients must have: 7. Received prior treatment with carboplatin and paclitaxel with a persistent CTCAE defined Grade 2 or worse neuropathy - Exclusion Criteria: Patients with any of the following will not be included in the study: Current diagnosis of comorbidity causing neuropathy (including peripheral vascular disease, lupus, Sjogren's syndrome, rheumatoid arthritis). Patients with diabetes may participate if baseline exam is negative for neuropathy symptoms and HbA1c < 7. Pregnant DVT diagnosed within 4 weeks prior to treatment Body weight greater 195kg Cohort A patients: 6. Previous treatment with taxane therapy 7. Preexisting diagnosis of neuropathy 8. Currently prescribed gabapentin, duloxetine or pregabalin Cohort B patients: 9. Diagnosis of neuropathy prior to cancer treatment -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>In this arm, patients with newly diagnosed gynecologic cancer starting chemotherapy treatment with carboplatin and paclitaxel will receive up to 8 cycles of SensoniQ treatment along with their chemotherapy (weekly or every 21 days depending on the regimen). | Device: SensoniQ Treatment Station<br>* The SensoniQ® Treatment Station is a chemotherapy chair with multiple transducers that release low- frequency sound waves to different points on the body in a preset frequency, distribution and time during a chemotherapy infusion.<br>* Other names: Wave Chair;|
| Experimental: Cohort B<br>In this arm, gynecologic cancer patients with persistent neuropathy following treatment with carboplatin and paclitaxel will receive a 30 minute SensoniQ treatment twice weekly for 4 weeks. | Device: SensoniQ Treatment Station<br>* The SensoniQ® Treatment Station is a chemotherapy chair with multiple transducers that release low- frequency sound waves to different points on the body in a preset frequency, distribution and time during a chemotherapy infusion.<br>* Other names: Wave Chair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACT/GOG-NTX & EORTC QLQ-CIPN20 | Percent of patients reporting neuropathy based on post treatment Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire (FACT/GOG NTX) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN Twenty Item Subscale (EORTC QLQ-CIPN20) scores (This primary outcome is specific to Cohort A) | 18 months | 
| FACT/GOG-NTX & EORTC QLQ CIPN-20 | Percent reduction in neuropathy based on post treatment FACT/GOG NTX and EORTC QLQ-CIPN 20 score compared to pretreatment score (This primary outcome measure is specific to Cohort B). | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic Exams | Change in score from pretreatment to post-treatment neurologic exams (Specific to both cohorts A & B). | 18 months | 
| FACT/GOG NTX & EORTC QLQ-CIPN 20 | Direct correlation of FACT/GOG NTX and EORTC QLQ-CIPN 20 scores to non-invasive neurologic scores (Specific to both cohorts A & B). | 18 months | 
| Safety & Tolerability | Safety and tolerability based on AEs, SAEs, & vital signs (Specific to both cohorts A & B). | 18 months | 
| Dose of chemotherapy | Total dose of chemotherapy (Specific to cohort A). | 18 months | 
| Overall Response Rate | ORR at 6 months post treatment per FACT/GOB NTX and EORTC QLQ-CIPN 20 scores and non-invasive neurologic test scores (specific to cohort B). | 18 months | 
| FACT/GOG NTX & EORTC QLQ-CIPN20 maximum reduction | Assess FACT/GOG NTX and EORTC QLQ-CIPN20 scores at each visit to determine the treatment number at which maximum reduction from baseline score is reported (specific to cohort B). | 18 months | 
| Treatment Completion | Time for treatment completion (Specific to cohort A). | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Neuropathy, Soundwave Stimulation