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

NCT05980169 | Active Not Recruiting FDA Device

• 1 other identifier: GCC-23-021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 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. 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

Conditions

Gynecologic Cancer; Neuropathy;Peripheral

Keywords

Chemotherapy; Neuropathy; Soundwave Stimulation

Outcome Measures

Primary Outcomes (2)

• 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)

  18 months

• 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).

  18 months

Secondary Outcomes (8)

• Neurologic Exams

  18 months

• FACT/GOG NTX & EORTC QLQ-CIPN 20

  18 months

• Safety & Tolerability

  18 months

• Dose of chemotherapy

  18 months

• Overall Response Rate

  18 months

Study Arms (2)

Cohort A

EXPERIMENTAL

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).

Device: SensoniQ Treatment Station

Cohort B

EXPERIMENTAL

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.

Device: SensoniQ Treatment Station

Interventions

SensoniQ Treatment Station 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.

Also known as: Wave Chair

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study protocol is specific to gynecological oncology studies. The study only applies to female patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. 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:
• \. Received prior treatment with a platinum agent and paclitaxel with a persistent CTCAE defined Grade 2 or worse neuropathy

You may not qualify if:

• 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.
• Pregnant
• DVT diagnosed within 4 weeks prior to treatment
• Body weight greater 195kg
• Cohort A patients:
• \. Previous treatment with taxane therapy 7. Preexisting diagnosis of neuropathy 8. Currently prescribed gabapentin, duloxetine or pregabalin
• Cohort B patients:
• \. Diagnosis of neuropathy prior to cancer treatment

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

James T Sonnenberg

Augusta, Georgia, 29607, United States

Location

MeSH Terms

Conditions

Neuritis

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 7, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)