Using soundwave stimulation to reduce chemotherapy-induced nerve damage in cancer patients

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

This study is testing whether soundwave therapy can help reduce nerve damage caused by chemotherapy in cancer patients receiving specific treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Augusta University (Academic / other)
• Drugs / interventions: Trastuzumab, Bevacizumab, Pembrolizumab, Dostarlimab, chemotherapy
• Locations: 1 site (Augusta, Georgia)
• Trial ID: NCT05980169 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the SensoniQ® Treatment Station in preventing or alleviating chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing carboplatin and paclitaxel chemotherapy for gynecologic cancers. The study aims to assess both the prevention of CIPN in newly treated patients and the improvement of existing neuropathy in those who have previously received these treatments. Participants will be monitored through questionnaires and neurologic tests to measure their response to the soundwave therapy during chemotherapy infusions. The goal is to provide a non-invasive intervention that could enhance patient quality of life and treatment adherence.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 or older with a histologically confirmed gynecologic malignancy receiving first-line chemotherapy with carboplatin and paclitaxel, or those with existing Grade 2 or worse CIPN from prior treatments.

Not a fit: Patients who do not have a gynecologic malignancy or are not receiving carboplatin and paclitaxel chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence and severity of CIPN, improving the quality of life for cancer patients undergoing chemotherapy.

How similar studies have performed: Previous studies using soundwave stimulation during chemotherapy have shown promising results in reducing neuropathy, suggesting potential success for this approach.

Eligibility criteria

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.

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

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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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Where this trial is running

Augusta, Georgia

• James T Sonnenberg — Augusta, Georgia, United States (Recruiting)

Study contacts

• Study coordinator: Marian S Johnson, MD

Conditions Gynecologic Cancer; Neuropathy; Peripheral; Chemotherapy; Soundwave Stimulation