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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT05335434
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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

Key Dates

Start date
Jun 10, 2022
Status verified
Dec 2025
Primary completion
Jun 20, 2026
Completion
Jul 19, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT
    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

Primary Outcome Measure

Duration of severe Oral Mucositis [ Time Frame: 20 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Kentaro Ikeda, DDS, DMSc
[email protected]
617-732-6570
Kentaro Ikeda, DDS, MPH (PRINCIPAL_INVESTIGATOR)
Nathaniel S. Treister, DMD, DMSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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