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Trial Title:
The Effect of Low Frequency Soundwave Stimulation on Chemotherapy Induced Peripheral Neuropathy
NCT ID:
NCT05980169
Condition:
Gynecologic Cancer
Neuropathy;Peripheral
Conditions: Official terms:
Peripheral Nervous System Diseases
Conditions: Keywords:
Chemotherapy
Neuropathy
Soundwave Stimulation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
SensoniQ Treatment Station
Description:
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.
Arm group label:
Cohort A
Arm group label:
Cohort B
Other name:
Wave Chair
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.
Criteria for eligibility:
Criteria:
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
-
Gender:
Female
Gender based:
Yes
Gender description:
This study protocol is specific to gynecological oncology studies. The study only applies
to female patients.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
James T Sonnenberg
Address:
City:
Augusta
Zip:
29607
Country:
United States
Status:
Recruiting
Contact:
Last name:
James T Sonnenberg, BS
Phone:
910-619-2597
Email:
JSONNENBERG@AUGUSTA.EDU
Contact backup:
Last name:
Eleanor Reeves, BS
Phone:
706-721-0730
Email:
ereeves@augusta.edu
Investigator:
Last name:
Marian S Johnson, MD
Email:
Principal Investigator
Start date:
November 29, 2023
Completion date:
December 1, 2029
Lead sponsor:
Agency:
Augusta University
Agency class:
Other
Source:
Augusta University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05980169
