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

NCT05335434 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-15

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Kentaro Ikeda, DDS, MPH · Brigham and Women's Hospital

  • Nathaniel S. Treister, DMD, DMSc · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2026-06-20
Completion
2026-07-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05335434 on ClinicalTrials.gov