Status:
RECRUITING
The Effect of Low Frequency Soundwave Stimulation on Chemotherapy Induced Peripheral Neuropathy
Lead Sponsor:
Augusta University
Conditions:
Gynecologic Cancer
Neuropathy;Peripheral
Eligibility:
FEMALE
18+ years
Phase:
NA
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 fro...
Detailed Description
Chemotherapy induced neuropathy symptoms (CIPNS) are a common side effect in patients undergoing treatment for gynecologic malignancies. The most common treatment is a combination of paclitaxel and ca...
Eligibility Criteria
Inclusion
- Patients must meet all the following inclusion criteria to be eligible for inclusion in the study:
- 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:
- 7\. Received prior treatment with a platinum agent and paclitaxel with a persistent CTCAE defined Grade 2 or worse neuropathy
- \-
Exclusion
- Patients with any of the following will not be included in the study:
- 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:
- 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
- \-
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05980169
Start Date
November 29 2023
End Date
December 1 2029
Last Update
November 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
James T Sonnenberg
Augusta, Georgia, United States, 29607