Actively Recruiting
A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation
Led by Dana-Farber Cancer Institute · Updated on 2025-12-15
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
T
THOR Photomedicine Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating intraoral photobiomodulation therapy (PBMT) to prevent oral mucositis, a painful mouth sore condition, in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). This pilot study is the first to assess a novel LED-based PBMT device called THOR LX2.3 with LED Lollipop, aiming to reduce inflammation and promote healing in patients receiving chemotherapy and immunosuppressive medications as part of their transplant preparation. Participants will receive daily intraoral PBMT using the THOR LX2.3 device starting from the beginning of conditioning chemotherapy until day +20 after transplant or until hospital discharge if earlier. Each treatment lasts about 2 to 3 minutes. The study treatment is administered daily for up to 27 consecutive days. The research includes screening for eligibility, daily treatments, and clinical evaluations. During the study, participants will be closely monitored with clinical assessments to measure the duration of severe oral mucositis over 20 days. Researchers will evaluate the effects of PBMT on oral health and potential side effects. The total participation time covers the period from conditioning through the early post-transplant phase, with safety and treatment responses carefully recorded throughout this time.
CONDITIONS
Brief Title
Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis
- Age 18 years or older
- Ability to understand and willingness to sign a written informed consent document
You will not qualify if you...
- Treatment with intraoral photobiomodulation within four weeks prior to admission for HSCT
- History of radiation therapy to the head and neck
- History of photosensitivity or underlying disease with known photosensitivity
- Planned to receive palifermin for oral mucositis prevention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 27 consecutive days
Participants receive daily intraoral photobiomodulation therapy (PBMT) starting from the beginning of conditioning chemotherapy through day +20, or until discharge if earlier. This therapy uses a device placed inside the mouth to deliver therapeutic light aimed at preventing oral mucositis.
Daily visits for up to 27 days
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
K
Kentaro Ikeda, DDS,MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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