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A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
Sponsor: Memorial Sloan Kettering Cancer Center
Summary
The purpose of this study is to find out whether photobiomodulation/PBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral Graft-Versus-Host Disease/GVHD.
Official title: A Multi-Center, Phase II, Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of Photobiomodulation for the Treatment of Oral Chronic Graft-Versus-Host Disease After Allogeneic Stem Cell Transplantation (the LIGHT Trial)
Key Details
Gender
All
Age Range
4 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2022-12-22
Completion Date
2026-12-22
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Photobiomodulation Therapy
Participants with a history of allo-HCT and diagnosis with oral chronic GvHD randomized to the treatment arm will be treated with oral photobiomodulation/PBM (via Thor LX2.3 system device) for 28 days
Placebo sham device
Participants with a history of allo-HCT and diagnosis with oral chronic GvHD randomized to the placebo arm will be treated with a placebo sham device (via Thor LX2.3 sham device setting) for 28 days
Locations (9)
National Institute of Health (Data Collection AND Specimen Analysis)
Bethesda, Maryland, United States
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York, United States
University of Pittsburgh Medical Center (Data Collection Only)
Pittsburgh, Pennsylvania, United States