Clinical trial NCT05980169: The Effect of Low Frequency Soundwave Stimulation on Chemotherapy Induced Peripheral Neuropathy
Official title: The Effect of Low Frequency Soundwave Stimulation on Chemotherapy Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Neuropathy;Peripheral
Keywords: Chemotherapy
Neuropathy
Soundwave Stimulation
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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.

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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Primary outcomes:
measure: FACT/GOG-NTX & EORTC QLQ-CIPN20
timeFrame: 18 months
measure: FACT/GOG-NTX & EORTC QLQ CIPN-20
timeFrame: 18 months
Secondary outcomes:
measure: Neurologic Exams
timeFrame: 18 months
measure: FACT/GOG NTX & EORTC QLQ-CIPN 20
timeFrame: 18 months
measure: Safety & Tolerability
timeFrame: 18 months
measure: Dose of chemotherapy
timeFrame: 18 months
measure: Overall Response Rate
timeFrame: 18 months
measure: FACT/GOG NTX & EORTC QLQ-CIPN20 maximum reduction
timeFrame: 18 months
measure: Treatment Completion
timeFrame: 18 months
measure: Sustained Response Assessment
timeFrame: 18months
Other outcomes:
Locations:
city: Augusta
country: United States
facility: James T Sonnenberg
state: Georgia
Study officials:
References: