Soundwave therapy shows promise for chemo nerve damage
NCT ID NCT05980169
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a device called SensoniQ® Treatment Station that uses low frequency soundwaves to prevent or reduce nerve pain caused by chemotherapy in people with gynecologic cancer. The trial includes 80 participants, some starting chemo and others with lasting nerve pain. Researchers will measure changes in neuropathy symptoms using questionnaires and exams.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 7\. 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: 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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James T Sonnenberg
Augusta, Georgia, 29607, United States
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Other studies related to the condition(s) this trial covers.
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