Trials / Enrolling By Invitation
Enrolling By InvitationNCT07061769
Helping Cancer Patients Manage Neuropathy Symptoms From Chemotherapy With a Low-Intensity, Low-Risk Cranial PEMF Device
Evaluating the Safety and Effectiveness of a Low Intensity Cranial PEMF Device in Improving Chemotherapy Induced Peripheral Neuropathy Symptoms
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- FluxWear, INC · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to examine a low-intensity, low-risk cranial PEMF device and its effectiveness with helping cancer patients manage neuropathy symptoms from chemotherapy. Eligible patients are individuals who have been diagnosed with chemotherapy-induced peripheral neuropathy or are experiencing pain due to chemotherapy and are eighteen to sixty. The main questions the study aims to answer are: To examine whether the application of low intensity, low frequency PEMF (by the System for Heterogeneous Integrated magnetic Field Transmission (SHIFT)) results in a significant decrease in neuropathic pain intensity. To examine if SHIFT results in a decrease of pain related interference and associated symptoms of CIPN. Researchers will compare an active, treatment arm to a placebo, SHAM arm. Participants will be required to use the device once daily, fill out daily, weekly, and monthly surveys. They will have to do one blood draw at the beginning of the study and one at the end of the study.
Conditions
- Chemotherapy Induced Peripheral Neuropathy
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
- Chemotherapy Induced Pain Neuropathy
- Chemotherapy Induced Neuropathic Pain
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SHIFT | SHIFT is a low intensity PEMF cranial device. It has been designated as a Non-Significant Risk device by the FDA. |
Timeline
- Start date
- 2025-06-23
- Primary completion
- 2026-06-01
- Completion
- 2026-07-15
- First posted
- 2025-07-11
- Last updated
- 2025-07-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07061769. Inclusion in this directory is not an endorsement.