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

Not Applicable

Recruiting

• Conditions: Gynecologic Cancer; Neuropathy;Peripheral
• Interventions: Device: SensoniQ Treatment Station

• Registration Number: NCT05980169
• Lead Sponsor: Augusta University

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 (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

Detailed Description

Chemotherapy induced neuropathy (CIPN) is 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 CIPN 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 CIPN in patients undergoing frontline chemotherapy with carboplatin and paclitaxel as well as improvement in patients with existing CIPN. This treatment has the potential to change recommendations for prevention of CIPN and improve adherence to treatment and quality of life.

Study Timeline

• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-07
• Study Start: 2023-11-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-12-01
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B	SensoniQ Treatment Station	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.
Cohort A	SensoniQ Treatment Station	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).

Primary Outcome Measures

Name	Time	Method
FACT/GOG-NTX & EORTC QLQ-CIPN20	18 months	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)
FACT/GOG-NTX & EORTC QLQ CIPN-20	18 months	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).

Secondary Outcome Measures

Name	Time	Method
Dose of chemotherapy	18 months	Total dose of chemotherapy (Specific to cohort A).
Neurologic Exams	18 months	Change in score from pretreatment to post-treatment neurologic exams (Specific to both cohorts A \& B).
FACT/GOG NTX & EORTC QLQ-CIPN20 maximum reduction	18 months	Assess FACT/GOG NTX and EORTC QLQ-CIPN20 scores at specified visits to determine the treatment number at which maximum reduction from baseline score is reported (specific to cohort B).
Safety & Tolerability	18 months	Safety and tolerability based on AEs \& SAEs related to the device (to both cohorts A \& B).
Overall Response Rate	18 months	ORR at 6 months post treatment per FACT/GOG NTX and EORTC QLQ-CIPN 20 scores and non-invasive neurologic test scores (specific to cohort B).
Treatment Completion	18 months	Time for treatment completion (Specific to cohort A).
FACT/GOG NTX & EORTC QLQ-CIPN 20	18 months	Direct correlation of FACT/GOG NTX and EORTC QLQ-CIPN 20 scores to non-invasive neurologic scores (Specific to both cohorts A \& B).
Sustained Response Assessment	18months	• Assess sustained response to treatment in patients who received 8 treatments versus patients who received 8 treatments with 6 maintenance treatments

Trial Locations

Locations (1)

James T Sonnenberg; 🇺🇸 Augusta, Georgia, United States