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

NCT ID: NCT05980169

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-29
• Study Completion Date: 2029-12-01

Brief 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. 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

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.

Conditions

Gynecologic Cancer; Neuropathy;Peripheral

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

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).

Group Type: EXPERIMENTAL

SensoniQ Treatment Station

Intervention Type: DEVICE

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.

Cohort B

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.

Group Type: EXPERIMENTAL

SensoniQ Treatment Station

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Wave Chair

Eligibility Criteria

Inclusion Criteria

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

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Exclusion Criteria

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

James T Sonnenberg

Augusta, Georgia, United States

Countries

United States

Other Identifiers

GCC-23-021

Identifier Type: -

Identifier Source: org_study_id