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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
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
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
National Institute of Health (Data Collection AND Specimen Analysis)
Bethesda, Maryland, United States
RECRUITINGMemorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States
Response rate of participants
To assess the primary objective, we will compare the treatment response rates, defined as the the proportion of oral GvHD allo-HCT patients who achieve a CR or a PR at Day 28, for the PBM and Placebo arms. The treatment response rate will be calculated within each study arm for all patients who completed at least one PBM or placebo treatment.
Time frame: 28 days
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Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Cancer Center @ Bergen (Consent only)
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Cancer Center @ Commack (Consent only)
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York, United States
RECRUITINGUniversity of Pittsburgh Medical Center (Data Collection Only)
Pittsburgh, Pennsylvania, United States
RECRUITING