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

A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation

This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Patients who are planned for alloHCT will receive daily intraoral photobiomodulation therapy (PBMT) using a novel LED device.

The name of the study device involved in this study is:

- THOR LX2.3 with LED Lollipop

Study Overview

• Status: Recruiting
• Conditions: Oral Mucositis; Myeloablative Allogeneic Hematopoietic Cell Transplantation; Intraoral Photobiomodulation Therapy; Mucosal Ulcer
• Intervention / Treatment: Device: THOR LX2.3 with LED Lollipop

Detailed Description

As part of a transplant procedure patients will receive chemotherapy in a conditioning regimen in preparation of alloHCT as well as immunosuppressive medications to help prevent graft-versus-host disease ("GVHD prophylaxis"). Together, these treatments will put patients at risk for developing side effects. A common side effect is oral mucositis (OM), in which mouth sores develop making eating and speaking difficult and painful.

Photobiomodulation therapy (PBMT) is a light-based therapy that reduces inflammation and enhances wound healing. PBMT delivered inside the mouth has been shown to reduce OM in patients undergoing alloHCT.

The name of the study device involved in this study is:

- THOR LX2.3 with LED Lollipop

This research study is a Pilot Study, which is the first time that investigators are examining this LED based intraoral PBMT.

The U.S. Food and Drug Administration (FDA) has not approved PBMT for this specific disease but it has been approved for other uses.

The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations.

Participants will receive study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first.

It is expected that about 20 people will take part in this research study

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kentaro Ikeda, DDS,MPH; Phone Number: 617-732-6570; Email: kikeda4@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Kentaro Ikeda, DDS, DMSc; Phone Number: 617-732-6570; Email: kikeda4@bwh.harvard.edu
      • Principal Investigator: Kentaro Ikeda, DDS, MPH
      • Principal Investigator: Nathaniel S. Treister, DMD, DMSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT; The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations. Participants will receive the study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first -THOR LX2.3 with LED Lollipop

Device: THOR LX2.3 with LED Lollipop; The intraoral PBMT device will be placed inside of the mouth to deliver the therapeutic light. Each treatment is approximately 2-3 minutes in duration. PBMT will be administered daily starting from the start of conditioning through day +20, or discharge if prior to day +20, with 27 consecutive days defined as a maximum PBMT treatment duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of severe Oral Mucositis	Defined as the total number of days between day 0 and day +20 on which severe (WHO grade 3 or 4) OM was reported	20 Days

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: THOR Photomedicine Ltd
• Investigators: Principal Investigator: Kentaro Ikeda, DDS, MPH, Brigham and Women's Hospital; Principal Investigator: Nathaniel S. Treister, DMD, DMSc, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 19, 2026

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Oral Mucositis; Myeloablative Allogeneic Hematopoietic Cell Transplantation (HCT); Intraoral Photobiomodulation Therapy; Mucosal Ulcer
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatitis
• Other Study ID Numbers: 22-036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes