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Smartwatch could spot nerve damage before it starts

NCT ID NCT06052345

Knowledge-focused Sponsor: Theodoros Foukakis Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This study follows women with early-stage breast cancer who are about to receive paclitaxel chemotherapy, a treatment that often causes nerve damage. Researchers will use smartwatches and a mobile app to track physical activity, sleep, and stress, alongside clinical exams and skin biopsies. The goal is to find early warning signs of nerve damage and understand how it affects quality of life over a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Garmin smartwatch and REBECCA mobile app for monitoring physical activity, sleep, stress, and location patterns
What this could lead to
If successful, this could lead to early detection and prevention of chemotherapy-induced nerve damage, improving quality of life for breast cancer patients.
What could go wrong
This is an observational study, so it won't test a treatment. It may not find clear predictors, and results may not apply to all patients.

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.

Started

Mar 2024

Finished

Dec 2025

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.

Who is studied

Patients will be identified as potential candidates and consecutively recruited from the oncology clinic at Karolinska University Hospital in Solna. Eligible candidates are patients who have been primarily operated for early non-metastatic breast cancer and are recommended by the multidisciplinary conference to receive adjuvant chemotherapy containing paclitaxel.

Ages

18 years and older

Sex

Female participants only

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: * Female patients * Age of ≥ 18 years * Newly operated primary breast cancer without metastatic disease receiving adjuvant chemotherapy containing paclitaxel * No prior chemotherapy other than cyclophosphamide and epirubicin * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Written informed consent * Able to communicate with investigators, participate in testing and comply with the requirements of the study-protocol Exclusion Criteria: * Have received drugs suspected/known to cause peripheral neuropathy * Have history of acquired or inherited neuropathy or other genetic disease with increased tendency to develop neuropathy * Have known disturbed glucose metabolism, either diabetes mellitus or impaired glucose tolerance * Have moderate to severe kidney, liver, lung or heart disease * Have known symptomatic or other advanced spinal stenosis * Have known autoimmune disease that potentially cause or contribute to neuropathy * Have known HIV or active HBV or HCV infections * Have known paraneoplastic syndrome * Have known alcohol abuse * Have known pregnancy or nursing

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm chemotherapy-induced neuropathy polyneuropathy polyneuropathy due to drug

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Breast neoplasms Chemotherapy-induced peripheral neuropathy Early-stage breast cancer Non-metastatic breast carcinoma Polyneuropathy due to drugs Polyneuropathy; drug Quality of life

Contacts and locations

Locations

  • Karolinska University Hospital

    Solna, Stockholm County, 171 76, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.