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Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Transplant Patients

This study is testing a new way to prevent painful mouth sores (oral mucositis) in people having a stem cell transplant (hematopoietic cell transplantation, or HCT). You might be able to join if you are at least 18 years old and are scheduled for a specific type of HCT using FluBu4 conditioning. The study will use a device called THOR LX2.3 with LED Lollipop, which delivers light therapy (photobiomodulation therapy or PBMT) inside your mouth daily. Researchers want to see if this treatment can reduce how long you experience severe mouth sores. This is a pilot study, meaning it's the first time this specific LED device is being tested for this purpose. The study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is a single-center pilot study, which is the first time this LED-based intraoral PBMT is being examined. It plans to enroll 20 participants.
What's involved
You would receive daily intraoral PBMT using the THOR LX2.3 with LED Lollipop device, starting from the beginning of your chemotherapy until day +20 after transplant, or until discharge if sooner. Each treatment takes about 2-3 minutes.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, duration of severe oral mucositis, will be measured at 20 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05335434

Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation

Recruiting
NAAges 18+InterventionalSupportive care
Dana-Farber Cancer Institute
~20 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:THOR LX2.3 with LED Lollipop

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Duration of severe Oral Mucositis
Measured over 20 Days

Conditions

Myeloablative Allogeneic Hematopoietic Cell Transplantation
Intraoral Photobiomodulation Therapy
Oral Mucositis
Mucosal Ulcer

Explore related trials

Hematopoietic Cell Transplantation

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Kentaro Ikeda, DDS, MPH · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
  • Nathaniel S. Treister, DMD, DMSc · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Kentaro Ikeda, DDS,MPH
[email protected]
617-732-6570
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Duration of severe Oral Mucositis20 Days

    Defined as the total number of days between day 0 and day +20 on which severe (WHO grade 3 or 4) OM was reported