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

NCT05335434 | Recruiting FDA Device

• 1 other identifier: 22-036
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Myeloablative Allogeneic Hematopoietic Cell Transplantation (HCT); Intraoral Photobiomodulation Therapy; Oral Mucositis; Mucosal Ulcer

Outcome Measures

Primary Outcomes (1)

• Duration of severe Oral Mucositis

  Defined as the total number of days between day 0 and day +20 on which severe (WHO grade 3 or 4) OM was reported

  20 Days

Study Arms (1)

INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT

EXPERIMENTAL

The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations. Participants will receive the 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 -THOR LX2.3 with LED Lollipop

Device: THOR LX2.3 with LED Lollipop

Interventions

THOR LX2.3 with LED Lollipop DEVICE

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

INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• THOR Photomedicine Ltd: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Kentaro Ikeda, DDS, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Nathaniel S. Treister, DMD, DMSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kentaro Ikeda, DDS,MPH

CONTACT

617-732-6570; kikeda4@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 19, 2022
• Study Start: June 10, 2022
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 19, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)