A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Graft-Versus-Host Disease; GVHD; Undefined

Treatments: Other: Placebo sham device; Device: Photobiomodulation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05675930

22-271

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)

Active Comparator group

Description:

Participants are Allo-HCT recipients

Treatment:

Device: Photobiomodulation Therapy

Adult and pediatric patients who received a placebo treatment

Placebo Comparator group

Description:

Participants are Allo-HCT recipients

Treatment:

Other: Placebo sham device