RECRUITING

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

Conditions

Graft-Versus-Host Disease GVHD Undefined Chronic Graft Versus Host Disease Oral PhotobiomoduLatIon Memorial Sloan Kettering Cancer Center 22-271

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to find out whether photobiomodulation/PBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral Graft-Versus-Host Disease/GVHD.

Official 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)

Quick Facts

Study Start:2022-12-22

Study Completion:2025-12-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05675930

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Alina Markova, MD

CONTACT

6466082342

markovaa@mskcc.org

Doris Ponce, MD

CONTACT

646-608-3739

ponced@mskcc.org

Principal Investigator

Alina Markova, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

National Institute of Health (Data Collection AND Specimen Analysis)

Bethesda, Maryland, 20892

United States

Memorial Sloan Kettering at Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Cancer Center @ Commack (Consent only)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Uniondale, New York, 11553

United States

Memorial Sloan Kettering Westchester (Consent only)

West Harrison, New York, 10604

United States

University of Pittsburgh Medical Center (Data Collection Only)

Pittsburg, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Alina Markova, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-22

Study Completion Date2025-12-22

Study Record Updates

Study Start Date2022-12-22

Study Completion Date2025-12-22

Terms related to this study

Keywords Provided by Researchers

Graft-Versus-Host Disease
GVHD
Chronic Graft Versus Host Disease Oral
PhotobiomoduLatIon
Memorial Sloan Kettering Cancer Center
22-271

Additional Relevant MeSH Terms

Graft-Versus-Host Disease
GVHD
Undefined