Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT05935956
Brief Summary:
Assess the safety and effectiveness of Axon Therapy in the treatment of chemotherapy-induced neuropathy
Detailed Description:
This is an observational, single arm, open label study in which up to 20 subjects diagnosed with chemotherapy induced neuropathy will be treated with mPNS.
Subjects will be consented, screened, and undergo a 7-day baseline assessment to measure pain scores and assess diary compliance. Subjects who meet inclusion criteria will undergo an in-clinic baseline evaluation and start their treatment.
All subjects will return to the clinic for follow-up assessment at Day 30 (± 14 days) and Day 90 (± 14 days) and will return to the clinic for mPNS treatments as follows:
* Month 1: 6 treatments
* WEEK 1: 3 treatments (consecutive treatments are best)
* WEEK 2-4: Weekly treatments
* Month 2: Bi-Weekly treatment
* Month 3: Treatments every 2-4 weeks
* Additional treatments to treat flare ups; defined as an episode of pain with a VAS of at least 5 following an increase in daily activities.
* The Lead Investigator is provided the discretion to modify the treatment protocol based on subject response.
In addition to in-clinic assessments and treatments, all subjects will complete an electronic twice daily diary through 90 days of the study. Subjects will receive weekly phone follow-up for diary reminders and to assess for the occurrence of adverse events after treatment starts. Weekly phone follow-ups will only occur during weeks when the subject is not seen in the clinic.
Study:
NCT05935956
Study Brief:
Protocol Section:
NCT05935956