Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation
A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation
Dana-Farber Cancer Institute
20 participants
Jun 10, 2022
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria3
- 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 Criteria4
- 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.
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Interventions
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
Locations(1)
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NCT05335434