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

Launched by AUGUSTA UNIVERSITY · Jul 31, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called SensoniQ® Treatment Station to see if it can help prevent or reduce a condition called chemotherapy-induced peripheral neuropathy (CIPN) in women receiving chemotherapy for gynecologic cancers. CIPN can cause symptoms like tingling, numbness, or pain in the hands and feet, which can be quite uncomfortable. The study will include two groups of participants: one group receiving chemotherapy for the first time with specific drugs, and another group who has already had chemotherapy but is still experiencing bothersome nerve symptoms.

To be eligible for this trial, participants must be at least 18 years old, have a confirmed gynecologic cancer, and be able to understand and participate in the study. They should not have other conditions causing nerve problems, be pregnant, or weigh more than 195 kg. Those who join the trial can expect to receive the SensoniQ treatment and undergo evaluations to measure its effects on their symptoms. This research is important as it aims to find new ways to improve the quality of life for women undergoing cancer treatment.

Gender

FEMALE

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
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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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