RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 frontline carboplatin and paclitaxel chemotherapy for a gynecologic malignancy. This study will also assess the improvement of CIPNS 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 CIPNS in gynecologic oncology patients receiving front line carboplatin and paclitaxel. 2. To investigate the efficacy of SensoniQ® Treatment Station on the improvement of existing CIPNS in patients who previously received chemotherapy with platinum agent and paclitaxel for a gynecologic malignancy

Official Title

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

Quick Facts

Study Start:2023-11-29
Study Completion:2029-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05980169

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients must be age 18 or older.
  2. 2. Histologically confirmed gynecologic malignancy.
  3. 3. Eastern Cooperative Oncology Group performance status of 0 to 2.
  4. 4. Be willing and able to participate in all required evaluations for the protocol
  5. 5. Speak, read, and understand English
  6. 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. 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.
  1. 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. 2. Pregnant
  3. 3. DVT diagnosed within 4 weeks prior to treatment
  4. 4. Body weight greater 195kg

Contacts and Locations

Study Contact

Marian S Johnson, MD
CONTACT
(706) 721-3992
MJOHNSON56@augusta.edu
James T Sonnenberg, BS
CONTACT
9106192597
JSONNENBERG@AUGUSTA.EDU

Study Locations (Sites)

James T Sonnenberg
Augusta, Georgia, 29607
United States

Collaborators and Investigators

Sponsor: Augusta University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-29
Study Completion Date2029-12-01

Study Record Updates

Study Start Date2023-11-29
Study Completion Date2029-12-01

Terms related to this study

Keywords Provided by Researchers

  • Chemotherapy
  • Neuropathy
  • Soundwave Stimulation

Additional Relevant MeSH Terms

  • Gynecologic Cancer
  • Neuropathy;Peripheral