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

Part of paid clinical trials in Newport Beach, California.

Sponsor
FluxWear, INC
Study ID
NCT07061769
Status
Enrolling By Invitation

Conditions

  • Chemotherapy Induced Neuropathic Pain
  • Chemotherapy Induced Pain Neuropathy
  • Chemotherapy Induced Peripheral Neuropathy
  • Chemotherapy Induced Peripheral Neuropathy (CIPN)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 23, 2025
Status verified
Jun 2025
Primary completion
Jun 1, 2026
Completion
Jul 15, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Device
  • Sham Comparator: Sham Device

Primary Outcome Measure

Decrease in Neuropathic Pain Intensity [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hoag Spine InstituteNewport BeachCalifornia92663-

Find similar trials in Newport Beach, CA

By research site
Hoag Spine Institute· Newport Beach, CA

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