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Photobiomodulation Therapy for the Treatment of Oral Chronic Graft-Versus-Host Disease after Donor Stem Cell Transplant, The LIGHT Trial
Trial Status: active
This phase II trial studies how well photobiomodulation (PBM) therapy using the Thor LX2.3 therapy system works in treating oral chronic graft-versus-host disease (GVHD) among patients who have undergone a donor stem cell transplant. When people have GVHD, the newly transplanted donor cells attack the transplant recipient’s body and cause serious health problems. Oral GVHD can cause white patches, redness, pain, and painless bumps in the mouth. It may make eating painful or cause sensitivity to certain foods. PBM therapy uses a device with red and near infra-red light to improve wound healing, decrease inflammation, and decrease pain on the parts of the body where it is applied. When cells in the body are exposed to this type of light, they make an enzyme called cytochrome oxidase c. This enzyme turns PBM light into energy, which is thought to help the cells damaged by GVHD to heal.
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
Additional locations may be listed on ClinicalTrials.gov for NCT05675930.
I. To assess oral chronic graft versus host disease (cGvHD) treatment response at day 28 after first photobiomodulatIon (PBM) treatment versus (vs) placebo as assessed by oral mucosal change in clinical National Institutes of Health (NIH)-modified Oral Mucositis Rating Scale (OMRS).
SECONDARY OBJECTIVES:
I. To assess the treatment response rate (TR) at days 56 and 84 days post-treatment initiation (or end of study if prior to day 56).
II. Treatment failure (TF) at days 28, 56, and 84 days post-treatment initiation (or end of study if prior to day 56).
III. To assess the change in Visual Analogue Scale score (VAS) for Mouth Pain by treatment arm at day 28.
IV. To assess the change in VAS for Mouth Pain by treatment arm at 1) day 56 and 2) day 84 days post-treatment initiation (or end of study if prior to day 56).
V. To evaluate the incidence of treatment-related adverse events through 28 days after the last PBM treatment.
VI. To evaluate the differences in oral health-related quality of life (OHRQoL) between PBM vs. placebo as determined by the Oral Health Impact Profile (OHIP-14: for ages >= 18 years) and Child Oral Health Impact Profile-Reduced (COHIP-SF 19: for ages 8 to < 18 years) at day 28.
VII. To assess and compare the systemic opioid needs for study participants for the treatment of oral cGvHD at day 28.
EXPLORATORY OBJECTIVES:
I. To assess the durability of the day 28 positive treatment response at day 56 (or end of treatment [EOT] if prior to day 56) amongst patients in the PBM group.
II. To investigate the dietary intake at screening, days 28 and 56 (or EOT if prior day 56); and at day 84 if a second cycle of treatment is applied.
III. To assess the saliva production between treatment arms at days 28, and 56 (or EOT if prior day 56); and day 84 if a second cycle of treatment is applied in patients ages >= 8 years.
IV. To investigate the effect of PBM in food preferences and taste at baseline and day 28.
V. To evaluate saliva to identify potential biomarkers of oral cGvHD disease activity and response to PBM in patients ages >= 8 years.
VI. To evaluate oral microbiota changes after PBM and placebo treatments.
VII. To evaluate oral mucosa using reflectance confocal microscopy before and after PBM and placebo treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo oral PBM therapy for one 4-week treatment cycle on study. Patients who achieve less than a complete response (CR) after 1 cycle then undergo an additional 4-week cycle of oral PBM therapy on study. Patients may also undergo reflectance confocal microscopy (RMC) during screening and on study.
ARM II: Patients undergo a placebo (sham) oral PBM therapy for one 4-week treatment cycle on study. Patients who achieve less than a CR after 1 cycle may then cross-over to Arm I and undergo one 4-week cycle of oral PBM therapy on study. Patients may also undergo RMC during screening and on study.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
