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
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
Description
As part of a transplant procedure patients will receive chemotherapy in a conditioning regimen in preparation of alloHCT as well as immunosuppressive medications to help prevent graft-versus-host disease ("GVHD prophylaxis"). Together, these treatments will put patients at risk for developing side effects. A common side effect is oral mucositis (OM), in which mouth sores develop making eating and speaking difficult and painful. Photobiomodulation therapy (PBMT) is a light-based therapy that reduces inflammation and enhances wound healing. PBMT delivered inside the mouth has been shown to redu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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 prev…
Interventions
- DeviceTHOR LX2.3 with LED Lollipop
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
Location
- Brigham and Women's HospitalBoston, Massachusetts