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Light therapy tested for painful mouth sores after stem cell transplant

NCT ID NCT05675930

Symptom relief Sponsor: Memorial Sloan Kettering Cancer Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether photobiomodulation (PBM) — a type of light therapy — can safely treat oral chronic graft-versus-host disease (GVHD), a painful mouth condition that can occur after a stem cell transplant. About 44 participants who have not responded to at least one prior treatment will receive either real PBM or a sham device for 28 days. The main goal is to see if the light therapy can reduce mouth sore severity.

What this could mean

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

Active substance
photobiomodulation (light therapy) using the Thor LX2.3 device
What this could lead to
If it works, this could offer a non-drug way to relieve painful mouth sores in people with chronic GVHD, improving their quality of life.
What could go wrong
This is a small, early-phase trial (44 people) testing a device, so results may not apply widely. The placebo effect from a sham device could also muddy the findings.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 44 people

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

Started

Dec 2022

Expected to finish

Dec 2026

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

4 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: * Allo-HCT recipients * Age ≥ 4 years-old * Oral cGvHD with NIH-modified OMRS score ≥ 3 who have failed ≥ 1 line of therapy, including topical corticosteroids.. * No change in systemic immunosuppressive therapy (type or intensity level) within 2 weeks prior to enrollment. * If a patient is currently using another oral topical treatment for mouth lesions/symptoms, patient must be stable on this treatment for ≥2 weeks prior to study enrollment. Patient may continue same topical dose/frequency during the study period. Exclusion Criteria: * Presence of an active uncontrolled infection. Subjects with a controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible. * Personal history of mucosal head and neck cancer in the past 5 years. * Pregnant or breastfeeding. * The subject or guardian is unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests. * Any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.

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Conditions

The condition(s) this trial relates to.

chronic graft versus host disease graft versus host disease

As listed by the trial registrant

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

Graft versus host disease GVHD Undefined

How to take part

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

  1. The places running it

    9 sites. 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

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center @ Commack (Consent only)

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Monmouth (Consent only)

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Westchester (Consent only)

    RECRUITING

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Basking Ridge (Consent only)

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • National Institute of Health (Data Collection AND Specimen Analysis)

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • University of Pittsburgh Medical Center (Data Collection Only)

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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