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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to assess the efficacy of SensoniQ® Treatment Station in preventing or reducing chemotherapy induced peripheral neuropathy (CIPN) in patients receiving frontline carboplatin and paclitaxel chemotherapy for a gynecologic malignancy. This study will also assess the improvement of CIPN 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 CIPN in gynecologic oncology patients receiving front line carboplatin and paclitaxel. 2. To investigate the efficacy of SensoniQ® Treatment Station on the improvement of existing CIPN in patients who previously received chemotherapy with platinum agent and paclitaxel for a gynecologic malignancy

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must be age 18 or older.

• Histologically confirmed gynecologic malignancy.

• Eastern Cooperative Oncology Group performance status of 0 to 2.

• Be willing and able to participate in all required evaluations for the protocol

• Speak, read, and understand English

• Cohort A patients must have:

• 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

⁃ \-

Locations
United States
Georgia
James T Sonnenberg
RECRUITING
Augusta
Contact Information
Primary
Marian S Johnson, MD
MJOHNSON56@augusta.edu
(706) 721-3992
Backup
James T Sonnenberg, BS
JSONNENBERG@AUGUSTA.EDU
9106192597
Time Frame
Start Date: 2023-11-29
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 80
Treatments
Experimental: 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).
Experimental: Cohort B
Cohort B was closed on April 1st 2025 due to not meeting the 30% improvement CIPN 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.
Related Therapeutic Areas
Sponsors
Leads: Augusta University

This content was sourced from clinicaltrials.gov