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Could a tiny ear device beat cancer fatigue?

NCT ID NCT07529431

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 13 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2035

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

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  1. The official record

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