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
- Are there results?
- Not yet: the study is under way
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
Show all 12Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Effectiveness of a Low Intensity Cranial PEMF Device in Improving Chemotherapy Induced Peripheral Neuropathy Symptoms
- ClinicalTrials.gov ID
- NCT07061769
- Acronym / sponsor ID
- 1391997
- Conditions
- Chemotherapy Induced Peripheral Neuropathy, Chemotherapy Induced Peripheral Neuropathy (CIPN), Chemotherapy Induced Pain Neuropathy, Chemotherapy Induced Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- FluxWear, INCIndustry (pharma, biotech, devices)
- Collaborators
- Hoag Memorial Hospital Presbyterian
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Device | Experimental | Device: SHIFT |
| Sham Device | Sham comparator | Device: SHIFT |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHIFTSHIFT is a low intensity PEMF cranial device. It has been designated as a Non-Significant Risk device by the FDA. | Device | Sham Device, Treatment Device |
Primary outcome
Decrease in Neuropathic Pain Intensity
Time frame: 12 weeks
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.
Decrease in Numeric Pain Rating.
Time frame: 12 weeks
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.
Improvement in Neuropathic Pain Symptoms
Time frame: 12 weeks
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.
4 secondary outcomes
Decrease of pain-related interference
Time frame: 12 weeks
Decrease of pain-related stress
Time frame: 12 weeks
Decrease of pain-related anxiety
Time frame: 12 weeks
Decrease of pain-related inflammatory markers
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Neuropathic Pain Intensity (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.