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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Kentaro Ikeda, DDS,MPH
kikeda4@bwh.harvard.edu
617-732-6570
Time Frame
Start Date: 2022-06-10
Estimated Completion Date: 2026-07-19
Participants
Target number of participants: 20
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute
Collaborators: THOR Photomedicine Ltd