Recruiting

Intraoral Photobiomodulation

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT05335434

Conditions

Myeloablative Allogeneic Hematopoietic Cell Transplantation

Intraoral Photobiomodulation Therapy

Oral Mucositis

Mucosal Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

THOR LX2.3 with LED Lollipop

Study Details

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

Conditions

Myeloablative Allogeneic Hematopoietic Cell Transplantation

Intraoral Photobiomodulation Therapy

Oral Mucositis

Mucosal Ulcer

Study ID

NCT05335434

Start date

Jun 10, 2022

Status verified date

Dec, 2025

Completion date

Jul 19, 2026

Anticipated

Primary completion date

Jun 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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

Primary outcome measure

  • Duration of severe Oral Mucositis [ Time Frame: 20 Days ]

Central Contacts and Locations

Central contacts

Kentaro Ikeda, DDS,MPH

617-732-6570kikeda4@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Kentaro Ikeda, DDS, DMSc

617-732-6570kikeda4@bwh.harvard.edu

Principal Investigator:

Kentaro Ikeda, DDS, MPH

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Myeloablative Allogeneic Hematopoietic Cell Transplantation (HCT)
  • Intraoral Photobiomodulation Therapy
  • Oral Mucositis
  • Mucosal Ulcer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2025-12-15.