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ENROLLING BY INVITATION
NCT07061769
NA

Helping Cancer Patients Manage Neuropathy Symptoms From Chemotherapy With a Low-Intensity, Low-Risk Cranial PEMF Device

Sponsor: FluxWear, INC

View on ClinicalTrials.gov

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.

Official title: Evaluating the Safety and Effectiveness of a Low Intensity Cranial PEMF Device in Improving Chemotherapy Induced Peripheral Neuropathy Symptoms

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-06-23

Completion Date

2026-07-15

Last Updated

2025-07-11

Healthy Volunteers

No

Interventions

DEVICE

SHIFT

SHIFT is a low intensity PEMF cranial device. It has been designated as a Non-Significant Risk device by the FDA.

Locations (1)

Hoag Spine Institute

Newport Beach, California, United States