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Gynecologic CancerNCT05980169

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

A study testing SensoniQ Treatment Station in people with Gynecologic Cancer and Neuropathy;Peripheral, run by Augusta University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gynecologic Cancer, Neuropathy;Peripheral
What is being tested?
SensoniQ Treatment Station
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
29 Nov 2023to 1 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: Patients must meet all the following inclusion criteria to be eligible for inclusion in the study:

  1. Patients must be age 18 or older.
  2. Histologically confirmed gynecologic malignancy.
  3. Eastern Cooperative Oncology Group performance status of 0 to 2.
  4. Be willing and able to participate in all required evaluations for the protocol
  5. Speak, read, and understand English Cohort A patients must have:
  6. Carboplatin and paclitaxel prescribed as first line treatment. Patients may also receive Trastuzumab, Bevacizumab, Pembrolizumab or Dostarlimab in conjunction with carboplatin and paclitaxel as these regimens are standard of care for specific cancers. Additional drugs may be acceptable after review and approval by the PI. In the event of a hypersensitivity reaction with paclitaxel, subjects may be switched to docetaxel and continue on study. In the event of a carboplatin hypersensitivity reaction, additional drugs or alterations to the treatment regimen may be changed after review and approval by the PI.

Cohort B patients must have:

  1. Received prior treatment with a platinum agent 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:

  1. 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.
  2. Pregnant
  3. DVT diagnosed within 4 weeks prior to treatment
  4. Body weight greater 195kg

Cohort A patients:

  1. Previous treatment with taxane therapy 7. Preexisting diagnosis of neuropathy 8. Currently prescribed gabapentin, duloxetine or pregabalin

Cohort B patients:

  1. Diagnosis of neuropathy prior to cancer treatment

-

Trial locations and contacts

1 site in 1 country.

United States1 site

  • James T Sonnenberg

    Augusta, Georgia, 29607

Other trials in United States

About this study

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:

  1. To investigate the efficacy of SensoniQ® Treatment Station on the prevention or reduction of CIPNS in gynecologic oncology patients receiving front line carboplatin and paclitaxel.
  2. To investigate the efficacy of SensoniQ® Treatment Station on the improvement of existing CIPNS in patients who previously received chemotherapy with platinum agent and paclitaxel for a gynecologic malignancy
Read the detailed description

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.

Being tested
SensoniQ Treatment Station
Keywords
Chemotherapy, Neuropathy, Soundwave Stimulation
Medical subject headings
Neuritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SensoniQ Treatment StationDevice

    Also called Wave Chair

    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.

Study groups in NCT05980169
Study groupRoleWhat they receive
Cohort AExperimentalIn 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).
Receives: Device: SensoniQ Treatment Station
Cohort BExperimentalCohort 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.
Receives: Device: SensoniQ Treatment Station

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 18 months

  2. 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).

    Measured: 18 months

Secondary outcomes (8)

  1. Neurologic Exams

    Change in score from pretreatment to post-treatment neurologic exams (Specific to both cohorts A \& B).

    Measured: 18 months

  2. 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).

    Measured: 18 months

  3. Safety & Tolerability

    Safety and tolerability based on AEs \& SAEs related to the device (to both cohorts A \& B).

    Measured: 18 months

  4. Dose of chemotherapy

    Total dose of chemotherapy (Specific to cohort A).

    Measured: 18 months

  5. 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).

    Measured: 18 months

  6. 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).

    Measured: 18 months

  7. Treatment Completion

    Time for treatment completion (Specific to cohort A).

    Measured: 18 months

  8. Sustained Response Assessment

    • Assess sustained response to treatment in patients who received 8 treatments versus patients who received 8 treatments with 6 maintenance treatments

    Measured: 18months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2023
  2. Study start29 Nov 2023
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05980169
Sponsor's protocol ID
GCC-23-021
Status last verified
Mar 2026
First submitted
10 Jul 2023
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing SensoniQ Treatment Station in people with Gynecologic Cancer and Neuropathy;Peripheral, run by Augusta University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FACT/GOG-NTX & EORTC QLQ-CIPN20 (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05980169.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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