A Phase II Study of Photobiomodulation Therapy in Children and Adults with Oral Graft-versus-Host Disease after Stem Cell Transplantation

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Full Title

A Multi-center, Phase II, Randomized Double-blind Trial to Evaluate the Efficacy and Safety of PhotobiomoduLatIon for the Treatment of Oral Chronic Graft-versus-Host Disease After Allogeneic Stem Cell Transplantation (The LIGHT Trial)

Purpose

The purpose of this study is to assess the safety and effectiveness of a specialized light treatment for children and adults with chronic graft-versus host disease (GVHD) of the mouth (oral GVHD) that has not improved after standard treatment. GVHD is a complication that can occur after a stem cell or bone marrow transplant. The newly transplanted donor cells attack the transplant recipient’s body and cause serious health problems. Oral GVHD can cause mouth inflammation, pain, and sores.

The light treatment in this study is called photobiomodulation (PBM) therapy. PBM uses a device with red and near infrared light to help wounds heal, decrease inflammation, and reduce pain on the parts of the body where it is applied.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have chronic GVHD of the mouth that is not getting better despite standard treatment.
  • This study is for people age 4 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Alina Markova at 646-608-2342.

Protocol

22-271

Phase

Phase II (phase 2)

Investigator

ClinicalTrials.gov ID

NCT05675930