This study is currently recruiting participants.
Number
000881-D
Sponsoring Institute
National Institute of Dental And Craniofacial Research (NIDCR)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 4 Years Max Age: 100 Years
Referral Letter Required
No
Population Exclusion(s)
None
Keywords
MUCOSITIS; Autoimmune; Low Level Laser Therapy; Ulcer; Oral Cavity
Recruitment Keyword(s)
Condition(s)
Chronic Graft-Versus-Host Disease
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Device: Photobiomodulation Device: Sham Photobiomodulation
Supporting Site
National Institute of Dental and Craniofacial Research
Stem cell transplants (allo-HCTs) are used to treat many diseases. But almost 70% of people who receive allo-HCTs develop chronic graft-versus-host disease (GvHD). GvHD causes serious health problems and can be fatal. When GvHD affects the mouth, it can cause issues including pain and ulcers. Better treatments are needed.
Objective:
To test a light therapy called photobiomodulation (PBM) to treat oral GvHD after allo-HCT.
Eligibility:
People aged 4 years and older who received allo-HCT and developed oral GvHD that failed at least 1 line of therapy.
Design:
Participants will be screened. They will have an oral exam. Images will be taken of the mouth. They will give saliva samples.
PBM uses probes or wands that produce light at therapeutic wavelengths. The wands will be placed on different parts of the inside of the mouth or on the outside of the cheeks and neck. Each treatment session takes 8 to 20 minutes. Participants will wear safety goggles.
Participants will be assigned to 1 of 2 groups. Half will receive PBM; half will receive a placebo treatment. The placebo treatment uses probes that emit light that is not therapeutic.
Participants will receive the light treatments 2 times a week for 4 weeks.
Participants who are not fully healed after 4 weeks may continue for another 4 weeks of treatment; at this time, those who had been receiving the placebo treatment will switch to PBM.
Participants will return for a follow-up visit 28 days after their last treatment.
--Back to Top--
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.
-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.
Principal Investigator
Referral Contact
For more information: