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RECRUITING
NCT05675930
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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

OTHER

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