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

NCT ID: NCT05335434

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2026-07-19

Brief Summary

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

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

THOR LX2.3 with LED Lollipop

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

THOR Photomedicine Ltd

UNKNOWN

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Kentaro Ikeda, DDS, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kentaro Ikeda, DDS, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Nathaniel S. Treister, DMD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kentaro Ikeda, DDS,MPH

Role: CONTACT

kikeda4@bwh.harvard.edu

617-732-6570

Facility Contacts

Kentaro Ikeda, DDS, DMSc

Role: primary

kikeda4@bwh.harvard.edu

617-732-6570

Other Identifiers

22-036

Identifier Type: -

Identifier Source: org_study_id