MedTrace Logo

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

NCT07061769 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-11

No results posted yet for this study

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

DEVICE

SHIFT

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

Sponsors & Collaborators

  • Hoag Memorial Hospital Presbyterian

    collaborator OTHER

  • FluxWear, INC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-23
Primary Completion
2026-06-01
Completion
2026-07-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07061769 on ClinicalTrials.gov