Could a tiny ear device beat cancer fatigue?
NCT ID NCT07529431
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a small, non-invasive device that stimulates a nerve in the ear can help reduce fatigue in cancer patients receiving immunotherapy. Thirteen adults with advanced cancer and significant fatigue will use the device at home for 60 minutes daily over six weeks. The main goal is to see if patients can stick with the routine and if the device is safe, while also checking for any improvement in tiredness and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous vagus nerve stimulation (tVNS) device
- What this could lead to
- If it works, this could point toward a new, drug-free way to manage severe fatigue in cancer patients on immunotherapy.
- What could go wrong
- This is a very small early feasibility study with only 13 participants. It is designed to test if the device can be used at home, not yet to prove it reduces fatigue.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 13 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or older * Histologically confirmed advanced or metastatic solid tumor * Receiving immune checkpoint inhibitor therapy and completed at least two cycles * Clinically significant fatigue (FACIT-F score ≤ 34) * ECOG performance status 0-2 * Life expectancy of at least 3 months * Ability to provide informed consent * Access to a smartphone or tablet Exclusion Criteria: * Current or planned chemotherapy, targeted therapy, or radiation during the 4-week intervention period. * Have received targeted therapy in the last 2 weeks * Have received chemotherapy or radiation therapy in the last 4 weeks * Symptomatic brain metastases defined as active neurologic complaint (headache, blurry vision, neurologic deficits or other symptom requiring treatment with steroids) * Long term steroid use \>10 mg prednisone equivalent daily * Active autoimmune disease requiring systemic immunosuppression * Implanted electronic medical devices (e.g., pacemakers, defibrillators) * History of epilepsy or vagal hypersensitivity * Known arrhythmia or bradycardia (Baseline HR \< 50 bpm) * Open wounds or dermatologic issues at the stimulation site * Pregnancy or breastfeeding * Participation in other fatigue-focused intervention trials * Severe uncontrolled psychiatric illness (PHQ-9 \>20)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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