Recruiting NCT05675930
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photobiomodulation Therapy, Placebo sham device.
- Who it may be relevant to
- Registry conditions: Graft-Versus-Host Disease, GVHD, Undefined. Basic parameters: from 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
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
Primary outcome measures
- Response rate of participants [Time frame: 28 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- National Institute of Health (Data Collection AND Specimen Analysis) — Bethesda
- Memorial Sloan Kettering at Basking Ridge (Consent only) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Consent only) — Middletown
- Memorial Sloan Kettering Cancer Center @ Bergen (Consent only) — Montvale
- Memorial Sloan Kettering Cancer Center @ Commack (Consent only) — Commack
- Memorial Sloan Kettering Westchester (Consent only) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) — Uniondale
- … and 1 more center
Identifiers
NCT: NCT05675930 · 22-271