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Behavioural Intervention
Low Frequency Soundwave Stimulation for Peripheral Neuropathy
N/A
Recruiting
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18months
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess if SensoniQ® Treatment Station can prevent or reduce CIPN in patients receiving frontline carboplatin & paclitaxel chemo for gynecologic cancer, and if it can improve existing CIPN in those who have had chemo.
Who is the study for?
This trial is for adults over 18 with gynecologic cancers who are about to start or have completed carboplatin and paclitaxel chemotherapy. Participants must not be pregnant, excessively overweight, or have certain preexisting conditions like severe neuropathy or diseases that cause it.
What is being tested?
The SensoniQ Treatment Station's ability to prevent or reduce chemotherapy-induced peripheral neuropathy in patients receiving frontline chemo for gynecologic malignancies is being tested. It also examines improvement in those with existing CIPN from such treatments.
What are the potential side effects?
While the trial description does not specify side effects of the SensoniQ Treatment Station, similar interventions may include discomfort at the treatment site, fatigue, and potential interference with other medical devices.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
FACT/GOG-NTX & EORTC QLQ CIPN-20
FACT/GOG-NTX & EORTC QLQ-CIPN20
Secondary study objectives
Dose of chemotherapy
FACT/GOG NTX & EORTC QLQ-CIPN 20
FACT/GOG NTX & EORTC QLQ-CIPN20 maximum reduction
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment1 Intervention
In this arm, gynecologic cancer patients with persistent neuropathy following treatment with platinum agent and paclitaxel will receive a 30 minute SensoniQ treatment twice weekly for 4 weeks.
Group II: Cohort AExperimental Treatment1 Intervention
In this arm, patients with newly diagnosed gynecologic cancer starting chemotherapy treatment with carboplatin and paclitaxel will receive up to 8 cycles of SensoniQ treatment along with their chemotherapy (weekly or every 21 days depending on the regimen).
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Who is running the clinical trial?
Augusta UniversityLead Sponsor
215 Previous Clinical Trials
85,610 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer diagnosis is confirmed and it affects my reproductive organs.I have a condition like lupus or diabetes but no nerve pain, and my blood sugar levels are controlled.My first treatment for cancer includes carboplatin and paclitaxel.I've been treated with carboplatin and paclitaxel and have ongoing severe nerve pain or damage.I was diagnosed with a deep vein thrombosis (DVT) less than 4 weeks ago.I was diagnosed with neuropathy before starting cancer treatment.I have had taxane therapy, have neuropathy, and take gabapentin, duloxetine, or pregabalin.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Cohort B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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