← Back to Search

Other

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,854 Total Patients Enrolled

Alina Markova, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

7 Previous Clinical Trials

803 Total Patients Enrolled

Media Library

Photobiomodulation Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05675930 — Phase 2

Graft-versus-Host Disease Research Study Groups: Adult and pediatric patients who received a placebo treatment, Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)

Graft-versus-Host Disease Clinical Trial 2023: Photobiomodulation Therapy Highlights & Side Effects. Trial Name: NCT05675930 — Phase 2

Photobiomodulation Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675930 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any availability for patients to join this clinical trial?

"Yes, the clinicaltrial.gov website shows that this experiment is still recruiting candidates. It was first published on December 22nd 2022 and has had a subsequent update since then; 44 people will be accepted at 7 distinct institutions for this investigation."

Answered by AI

Has the FDA approved allogeneic stem cell transplant (allo-HCT) for both adult and pediatric patients?

"Given the Phase 2 status of this clinical trial, our team at Power assessed the safety level of allogeneic stem cell transplant recipients as a 2 due to partial data regarding its relative security."

Answered by AI

What is the cap on participants for this experiment?

"Affirmative. The clinicaltrial.gov page for this trial confirms that recruitment is in progress, having been initially posted on December 22nd 2022 and last updated on the same date. A total of 44 individuals are being sought from 7 different medical centres."

Answered by AI

How many locations have been designated for this trial's implementation?

"Presently, there are 7 research facilities that are partaking in this clinical trial. These include Memorial Sloan Kettering Monmouth (Consent only) in Middletown, Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)in Montvale andMemorial Sloan Kettering Cancer Center @ Commack (Consent only)in Commack among others."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05675930.

All > Gvhd