Chemotherapy Induced Peripheral NeuropathyNCT07061769
Helping Cancer Patients Manage Neuropathy Symptoms From Chemotherapy With a Low-Intensity, Low-Risk Cranial PEMF Device
A study testing SHIFT in people with Chemotherapy Induced Peripheral Neuropathy and Chemotherapy Induced Peripheral Neuropathy (CIPN), run by FluxWear, INC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy, Chemotherapy Induced Peripheral Neuropathy (CIPN), Chemotherapy Induced Pain Neuropathy
- What is being tested?
- SHIFT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2025to 15 Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to use smart phone and willing to receive text messages/emails
- Has CIPN disorder/neuropathic pain related to chemotherapy
- Able and willing to follow instructions
- Not participated in any other clinical study within the past two months that may influence the results of this study
Who cannot join
- History of seizures
- Hydrocephalic
- Had a change in medical therapy related to the treatment of neuropathy or chronic pain in the last fourteen days
- Received repetitive transcranial magnetic stimulation (rTMS) in the last 60 days
- Implanted device or metal in the brain
- History of brain bleed in the last six months
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- History of suicidal behavior, bipolar disorder, schizophrenia
- Active radiation over the scalp
- Brain metastases
- Currently participates in other neuropathic pain studies
- Has any other medical condition that would prevent them from participating, including scalp wounds, hyperhidrosis, sensitive scalp, rash
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hoag Spine Institute
Newport Beach, California, 92663
About this study
Official title: Evaluating the Safety and Effectiveness of a Low Intensity Cranial PEMF Device in Improving Chemotherapy Induced Peripheral Neuropathy Symptoms
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.
Read more
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHIFTDevice
SHIFT is a low intensity PEMF cranial device. It has been designated as a Non-Significant Risk device by the FDA.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Device | Experimental | Not described Receives: Device: SHIFT |
| Sham Device | Sham comparator | Not described Receives: Device: SHIFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Neuropathic Pain Intensity
Measured through scores in the Neuropathy Pain Scale. The Neuropathy Pain Scale uses a range a 0 to 10, with 0 being no pain/sensation and 10 being the most intense pain/sensation imaginable.
Measured: 12 weeks
Decrease in Numeric Pain Rating.
Measured through Numeric Pain Rating surveys. The numeric pain rating scale uses a range of 0 to 10, with 0 being no pain and 10 being the worst pain possible.
Measured: 12 weeks
Improvement in Neuropathic Pain Symptoms
Measured in weekly scores in the Neuropathic Pain Symptom Inventory. The inventory uses a scale of 1 to 10, with 1 being the no symptom and 10 being the worst symptom imaginable.
Measured: 12 weeks
Secondary outcomes (4)
Decrease of pain-related interference
Examine if SHIFT results in a decrease of pain related interferences on a weekly basis. The PEG scale assesses how much pain interferes with weekly abilities on a scale of 0 to 10, with 0 being no interference/pain and ten being complete interference/worst pain imaginable.
Measured: 12 weeks
Decrease of pain-related stress
Examine if SHIFT results in a decrease of perceived stress related to pain on a weekly basis, using the perceived stress scale. The PSS examines how well patients have been able to sleep on a scale of 0 to 4 (0 being never and 4 being very often).
Measured: 12 weeks
Decrease of pain-related anxiety
Examine if SHIFT results in a decrease of anxiety related to pain as measured by the GAD-7. The GAD 7 uses a scale of 0 (not at all) to 3 (nearly every day) to measure how often a patient feels anxiety.
Measured: 12 weeks
Decrease of pain-related inflammatory markers
Examine if SHIFT results in a decrease of inflammatory markers in the blood, specifically a decrease in the presence of IL-6.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start23 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FluxWear, INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoag Memorial Hospital Presbyterian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061769
- Sponsor's protocol ID
- 1391997
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided