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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • THOR LX2.3 with LED Lollipop

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Dana-Farber Cancer Institute

Lead sponsor

THOR Photomedicine Ltd

Collaborator