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Could a daily 'Lollipop' light stop mouth sores in transplant patients?

NCT ID NCT05335434

Prevention Sponsor: Dana-Farber Cancer Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a daily light therapy device placed inside the mouth to prevent severe mouth sores in people receiving a stem cell transplant. Twenty adults will use the device for about 2-3 minutes each day from the start of their conditioning chemotherapy through day 20 after transplant. The main goal is to see how many days of severe mouth sores occur, compared to what is normally expected.

What this could mean

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

Active substance
THOR LX2.3 with LED Lollipop (a light-emitting device placed in the mouth)
What this could lead to
If it works, this could offer a simple, non-drug way to prevent painful mouth sores during stem cell transplant recovery.
What could go wrong
This is a very small pilot study with only 20 people, so results may not apply to everyone. The device may not reduce sores more than standard care.

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 20 people

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

Started

Jun 2022

Expected to finish

Jul 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

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: * Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis. * Age ≥18 years. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who have had treatment with intraoral PBMT within four weeks of admission for HSCT. * Participants who have a history of radiation therapy to the head and neck. * Participants who have a history of photosensitivity or underlying disease with known photosensitivity. * Participants who are planned to receive palifermin for OM prevention.

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Conditions

The condition(s) this trial relates to.

ulcer disease stomatitis prevention target

As listed by the trial registrant

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

Intraoral photobiomodulation therapy Mucosal ulcer Myeloablative allogeneic hematopoietic cell transplantation Oral mucositis

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

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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