Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT07061769
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-11
First Post:
2025-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Helping Cancer Patients Manage Neuropathy Symptoms From Chemotherapy With a Low-Intensity, Low-Risk Cranial PEMF Device
Sponsor:
FluxWear, INC
Organization:
Study Overview
Official Title:
Evaluating the Safety and Effectiveness of a Low Intensity Cranial PEMF Device in Improving Chemotherapy Induced Peripheral Neuropathy Symptoms
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: