NCT05335434

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 reduce OM in patients undergoing alloHCT. The name of the study device involved in this study is: \- THOR LX2.3 with LED Lollipop This research study is a Pilot Study, which is the first time that investigators are examining this LED based intraoral PBMT. The U.S. Food and Drug Administration (FDA) has not approved PBMT for this specific disease but it has been approved for other uses. The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations. Participants will receive study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first. It is expected that about 20 people will take part in this research study

Conditions

• Myeloablative Allogeneic Hematopoietic Cell Transplantation
• Intraoral Photobiomodulation Therapy
• Oral Mucositis
• Mucosal Ulcer

Interventions

Type	Name	Description
DEVICE	THOR 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

Timeline

• Start date: 2022-06-10
• Primary completion: 2026-06-20
• Completion: 2026-07-19
• First posted: 2022-04-19
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study