NCT05675930PHASE2Recruiting
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
Memorial Sloan Kettering Cancer Center
Start Date
12/22/2022
Completion Date
12/22/2026
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.
Eligibility Criteria
Age Range: 4 years to No maximum
Inclusion Criteria:
* Allo-HCT recipients
* Age ≥ 4 years-old
* Oral cGvHD with NIH-modified OMRS score ≥ 3 who have failed ≥ 1 line of therapy, including topical corticosteroids..
* No change in systemic immunosuppressive therapy (type or intensity level) within 2 weeks prior to enrollment.
* If a patient is currently using another oral topical treatment for mouth lesions/symptoms, patient must be stable on this treatment for ≥2 weeks prior to study enrollment. Patient may continue same topical dose/frequency during the study period.
Exclusion Criteria:
* Presence of an active uncontrolled infection. Subjects with a controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible.
* Personal history of mucosal head and neck cancer in the past 5 years.
* Pregnant or breastfeeding.
* The subject or guardian is unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests.
* Any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Interventions
DEVICE
Photobiomodulation Therapy
OTHER
Placebo sham device
Conditions
Graft-Versus-Host DiseaseGVHDUndefined
Locations
National Institute of Health (Data Collection AND Specimen Analysis)
Bethesda, Maryland 20892
United States
Memorial Sloan Kettering at Basking Ridge (Consent only)
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United States
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York 11553
United States
University of Pittsburgh Medical Center (Data Collection Only)
Pittsburgh, Pennsylvania 15213
United States