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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05980169
• Other study ID #: GCC-23-021
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2029

Study information

• Verified date: October 2023
• Source: Augusta University
• Contact: Marian S Johnson, MD
• Phone: (706) 721-3992
• Email: MJOHNSON56[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 carboplatin and paclitaxel for a gynecologic malignancy

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2029
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Cohort B patients must have:

7. Received prior treatment with carboplatin 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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Related Conditions & MeSH terms

• Gynecologic Cancer
• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	James T Sonnenberg	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Neurologic Exams	Change in score from pretreatment to post-treatment neurologic exams (Specific to both cohorts A & B).	18 months
Secondary	FACT/GOG NTX & EORTC QLQ-CIPN 20	Direct correlation of FACT/GOG NTX and EORTC QLQ-CIPN 20 scores to non-invasive neurologic scores (Specific to both cohorts A & B).	18 months
Secondary	Safety & Tolerability	Safety and tolerability based on AEs, SAEs, & vital signs (Specific to both cohorts A & B).	18 months
Secondary	Dose of chemotherapy	Total dose of chemotherapy (Specific to cohort A).	18 months
Secondary	Overall Response Rate	ORR at 6 months post treatment per FACT/GOB NTX and EORTC QLQ-CIPN 20 scores and non-invasive neurologic test scores (specific to cohort B).	18 months
Secondary	FACT/GOG NTX & EORTC QLQ-CIPN20 maximum reduction	Assess FACT/GOG NTX and EORTC QLQ-CIPN20 scores at each visit to determine the treatment number at which maximum reduction from baseline score is reported (specific to cohort B).	18 months
Secondary	Treatment Completion	Time for treatment completion (Specific to cohort A).	18 months