An interventional study of SensoniQ Treatment Station in Gynecologic Cancer and Neuropathy;Peripheral, sponsored by Augusta University. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Augusta University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to assess the efficacy of SensoniQ® Treatment Station in preventing or reducing chemotherapy induced peripheral neuropathy symptoms (CIPNS) in patients receiving frontline carboplatin and paclitaxel chemotherapy for a gynecologic malignancy. This study will also assess the improvement of CIPNS 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:
Chemotherapy induced neuropathy symptoms (CIPNS) are 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 CIPNS 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 CIPNS in patients undergoing frontline chemotherapy with carboplatin and paclitaxel as well as improvement in patients with existing CIPNS. This treatment has the potential to change recommendations for prevention of CIPNS and improve adherence to treatment and quality of life.
73 studies on the registry are indexed under Neuritis; 20 are open to participants now.
This study's planned enrollment of 80 is above the median of 48 across 51 interventional studies indexed under Neuritis.
Browse Neuritis studies →Augusta University is the lead sponsor of 180 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patients must meet all the following inclusion criteria to be eligible for inclusion in the study:
Speak, read, and understand English
Cohort A patients must have:
Cohort B patients must have:
7. Received prior treatment with a platinum agent and paclitaxel with a persistent defined Grade 2 or worse neuropathy
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Exclusion Criteria: Patients with any of the following will not be included in the study:
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
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Cohort B was closed on April 1st, 2025 due to not meeting the 30% improvement CIPNS objective. Enrollment was closed for Cohort B and all maintenance treatment and follow-ups were discontinued. No safety issues were identified during data analysis. In this arm, gynecologic cancer patients with persistent neuropathy following treatment with platinum agent and paclitaxel will receive a 30-minute SensoniQ treatment twice weekly for 4 weeks.
Device: SensoniQ Treatment Station
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.
Also known as: Wave Chair
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)
Time frame: 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).
Time frame: 18 months
Neurologic Exams
Change in score from pretreatment to post-treatment neurologic exams (Specific to both cohorts A \& B).
Time frame: 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).
Time frame: 18 months
Safety & Tolerability
Safety and tolerability based on AEs \& SAEs related to the device (to both cohorts A \& B).
Time frame: 18 months
Dose of chemotherapy
Total dose of chemotherapy (Specific to cohort A).
Time frame: 18 months
Overall Response Rate
ORR at 6 months post treatment per FACT/GOG NTX and EORTC QLQ-CIPN 20 scores and non-invasive neurologic test scores (specific to cohort B).
Time frame: 18 months
FACT/GOG NTX & EORTC QLQ-CIPN20 maximum reduction
Assess FACT/GOG NTX and EORTC QLQ-CIPN20 scores at specified visits to determine the treatment number at which maximum reduction from baseline score is reported (specific to cohort B).
Time frame: 18 months
Treatment Completion
Time for treatment completion (Specific to cohort A).
Time frame: 18 months
Sustained Response Assessment
• Assess sustained response to treatment in patients who received 8 treatments versus patients who received 8 treatments with 6 maintenance treatments
Time frame: 18months
Started Nov 2023 (actual). Primary completion is estimated for Jun 2026, 30 months after the start.
Of 23 interventional studies with no phase under Neuritis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's planned 30 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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