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Light therapy tested to reverse radiation damage in head and neck cancer patients

NCT ID NCT06708754

Symptom relief Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 special light therapy called photobiomodulation (PBM) can reduce swelling and tissue hardening caused by radiation treatment in head and neck cancer survivors. Sixty participants who completed radiation at least 3 months ago will be randomly assigned to receive either real PBM or a sham device. Researchers will measure changes in soft tissue thickness using ultrasound to see if the light therapy helps.

What this could mean

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

Active substance
Photobiomodulation (PBM) therapy using a light-emitting diode (LED) device
What this could lead to
If it works, this could point toward a non-invasive way to ease chronic swelling and stiffness after radiation for head and neck cancer.
What could go wrong
This is a small early feasibility study, not a large definitive trial. The sham control means some participants may not benefit, 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.

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 60 people

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

Started

Feb 2025

Expected to finish

Feb 2030

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: * Patients treated with radiation for head and neck cancer who are ≥ 3 months \< 36 months post-RT (last RT). * Patients who received at least 50Gy of bilateral neck RT. Subjects who received RT or concurrent chemoradiation (chemoRT) therapy for HNC are eligible. * No evidence of disease as documented by imaging 3 months after completion of RT. * Common Terminology Criteria for Adverse Events (CTCAE) fibrosis score ≥ 2 at enrollment. * Patient who has body mass index (BMI) \>30 at the time of enrollment may be excluded at a discretion of the principal investigator if fibrotic areas cannot be identified by clinical objective assessment of fibrosis. * Willing to comply with all study procedures and be available for the duration of the study. Exclusion Criteria: * Woman who are pregnant or planning to become pregnant or breast-feeding. * Patients enrolled on another drug or device investigational trial for prevention or treatment of LEF. * Patients deprived of freedom, under supervision or guardianship. * Patients unable to attend to scheduled visits due to geographical, social or mental reasons. * Patients who received prior PBM therapy for RT toxicities in the last year; * Patients who report being photosensitive. * Patients who have chronic immunosuppression or are on current immunosuppressive therapies. * Any patient who, in the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms Radiation Fibrosis Syndrome radiation pneumonitis

As listed by the trial registrant

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

Head and neck cancer Radiation fibrosis Radiation lymphedema

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

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