Photobiomodulation for the Prevention of Oral Mucositis

NCT07290413 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: 25-137
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if photobiomodulation works to prevent severe oral mucositis in patients who are undergoing allogeneic hematopoietic cell transplantation. The main questions it aims to answer are: Does 1) intraoral , 2) extraoral, or 3) combined intraoral/extraoral photobiomodulation have optimal prevention/therapeutic effect in prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation (alloHSCT). Participants will: Be randomized to one of the three treatment arms Receive daily photobiomodulation therapy (from beginning of transplant conditioning through Day +20 after transplantation) Be evaluated for oral mucositis and symptoms daily Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Duration of severe oral mucositis according to the World Health Organization Oral Toxicity Score

  WHO Score (0-4, "severe" defined as grades 3 and 4)

  Oral mucositis is assessed daily from day 0 through day +20

Study Arms (3)

Intraoral photobiomodulation

EXPERIMENTAL

Intraoral PBMT device: The THOR intraoral PBMT device emits LED light with an irradiance of 50 mW/cm2 and, when applied for 60 seconds, delivers 3 J/cm2. It is a handheld device with an array of LEDs covered by smooth glass. The therapeutic area is small enough (similar to a popsicle) to place in the mouth comfortably.

Device: Photobiomodulation - INTRAORAL

Extraoral photobiomodulation

EXPERIMENTAL

Extraoral PBMT device: The extraoral PBMT device is a dual headed probe designed to be connected to the LX2.3 Laser and LED Therapy System. It consists of two high-powered probes designed to emit 850nm light at an intensity of 240 m/cm2. The device is dual-headed in order to treat both sides of the head simultaneously without the need for a sperate control unit.

Device: Photobiomodulation - EXTRAORAL

Combined intraoral and extraoral photobiomodulation

EXPERIMENTAL

Participants in this arm will receive both intraoral and extraoral photobiomodulation.

Device: Photobiomodulation - INTRAORAL and EXTRAORAL

Interventions

Photobiomodulation - INTRAORAL DEVICE

Participants will receive intraoral photobiomodulation

Intraoral photobiomodulation

Photobiomodulation - EXTRAORAL DEVICE

Participants will receive extraoral photobiomodulation

Extraoral photobiomodulation

Photobiomodulation - INTRAORAL and EXTRAORAL DEVICE

Participants will receive intraoral and extraoral photobiomodulation

Combined intraoral and extraoral photobiomodulation

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned to undergo myeloablative allogeneic HCT (with one of the following regimens): FluBu4, FluMel, or CyTBI conditioning and Tac-Mtx GVHD prophylaxis
• Age ≥4 years
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Participants who have had treatment with oral 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 (keratinocyte growth factor) for OM prevention.
• Participants who have facial hair and unwilling to shave.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Surgeon

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)