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

Description

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

Conditions

Gynecologic Cancer, Neuropathy;Peripheral

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Gynecologic Cancer
Intervention / Treatment

-

Contacts and Locations

Augusta

James T Sonnenberg, Augusta, Georgia, United States, 29607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • 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.
  • 7. Received prior treatment with a platinum agent and paclitaxel with a persistent CTCAE defined Grade 2 or worse neuropathy
  • 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
  • 6. Previous treatment with taxane therapy 7. Preexisting diagnosis of neuropathy 8. Currently prescribed gabapentin, duloxetine or pregabalin
  • 9. Diagnosis of neuropathy prior to cancer treatment

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Augusta University,

Study Record Dates

2029-12-01