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Photobiomodulation Therapy for Oral Graft-Versus-Host Disease
Phase 2
Recruiting
Led By Alina Markova, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Summary
This trial studies if a light therapy called PBM is safe and helpful for treating GVHD in the mouth.
Who is the study for?
This trial is for people aged 4 or older with oral Graft-Versus-Host Disease after a stem cell transplant. They must have an NIH-modified OMRS score of at least 3, failed one line of therapy like topical corticosteroids, and been stable on any current oral treatments for two weeks. Pregnant or breastfeeding individuals, those with uncontrolled infections, or unable to follow the study plan are excluded.
What is being tested?
The study tests if Photobiomodulation (PBM) Therapy using the Thor LX2.3 system can safely and effectively treat oral GVHD compared to a placebo sham device. Participants will be randomly assigned to receive either PBM therapy or a sham treatment as part of the research.
What are the potential side effects?
Specific side effects of PBM therapy aren't detailed here but generally may include discomfort at the site of application, headaches, tiredness, and in rare cases changes in skin pigmentation where treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response rate of participants
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)Active Control1 Intervention
Participants are Allo-HCT recipients
Group II: Adult and pediatric patients who received a placebo treatmentPlacebo Group1 Intervention
Participants are Allo-HCT recipients
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,315 Total Patients Enrolled
Alina Markova, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
772 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 4 years old or older.I had mucosal head or neck cancer within the last 5 years.I haven't changed my immunosuppressive medication in the last 2 weeks.I have severe oral complications from a transplant and treatments haven't worked.I have been on a stable dose of oral treatment for mouth issues for 2+ weeks.I am unable to understand or follow the study's requirements.I do not have an active, uncontrolled infection or have been treating it for at least 48 hours.
Research Study Groups:
This trial has the following groups:- Group 1: Adult and pediatric patients who received a placebo treatment
- Group 2: Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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