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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05980169
Other study ID # GCC-23-021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 1, 2029

Study information

Verified date October 2023
Source Augusta University
Contact Marian S Johnson, MD
Phone (706) 721-3992
Email MJOHNSON56@augusta.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 carboplatin and paclitaxel for a gynecologic malignancy


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 1, 2029
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Cohort B patients must have: 7. Received prior treatment with carboplatin and paclitaxel with a persistent CTCAE defined Grade 2 or worse neuropathy - 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 -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SensoniQ Treatment Station
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.

Locations

Country Name City State
United States James T Sonnenberg Augusta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary FACT/GOG-NTX & EORTC QLQ-CIPN20 Percent of patients reporting neuropathy based on post treatment Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire (FACT/GOG NTX) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN Twenty Item Subscale (EORTC QLQ-CIPN20) scores (This primary outcome is specific to Cohort A) 18 months
Primary FACT/GOG-NTX & EORTC QLQ CIPN-20 Percent reduction in neuropathy based on post treatment FACT/GOG NTX and EORTC QLQ-CIPN 20 score compared to pretreatment score (This primary outcome measure is specific to Cohort B). 18 months
Secondary Neurologic Exams Change in score from pretreatment to post-treatment neurologic exams (Specific to both cohorts A & B). 18 months
Secondary FACT/GOG NTX & EORTC QLQ-CIPN 20 Direct correlation of FACT/GOG NTX and EORTC QLQ-CIPN 20 scores to non-invasive neurologic scores (Specific to both cohorts A & B). 18 months
Secondary Safety & Tolerability Safety and tolerability based on AEs, SAEs, & vital signs (Specific to both cohorts A & B). 18 months
Secondary Dose of chemotherapy Total dose of chemotherapy (Specific to cohort A). 18 months
Secondary Overall Response Rate ORR at 6 months post treatment per FACT/GOB NTX and EORTC QLQ-CIPN 20 scores and non-invasive neurologic test scores (specific to cohort B). 18 months
Secondary FACT/GOG NTX & EORTC QLQ-CIPN20 maximum reduction Assess FACT/GOG NTX and EORTC QLQ-CIPN20 scores at each visit to determine the treatment number at which maximum reduction from baseline score is reported (specific to cohort B). 18 months
Secondary Treatment Completion Time for treatment completion (Specific to cohort A). 18 months
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