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
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.
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.
Single group
THOR LX2.3 with LED Lollipop
DeviceThe 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
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
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
THOR Photomedicine Ltd
Collaborator
