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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05675930
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Photobiomodulation Therapy — DEVICE
    Participants with a history of allo-HCT and diagnosis with oral chronic GvHD randomized to the treatment arm will be treated with oral photobiomodulation/PBM (via Thor LX2.3 system device) for 28 days
  • Placebo sham device — OTHER
    Participants with a history of allo-HCT and diagnosis with oral chronic GvHD randomized to the placebo arm will be treated with a placebo sham device (via Thor LX2.3 sham device setting) for 28 days

Study Details

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.

Key Dates

Start date
Dec 22, 2022
Status verified
May 2026
Primary completion
Dec 22, 2026
Completion
Dec 22, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)
    Participants are Allo-HCT recipients
  • Placebo Comparator: Adult and pediatric patients who received a placebo treatment
    Participants are Allo-HCT recipients

Primary Outcome Measure

Response rate of participants [ Time Frame: 28 days ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
National Institute of Health (Data Collection AND Specimen Analysis)BethesdaMaryland20892
Jacqueline Mays, DDS, MHSc, PhD
[email protected]
(301) 496-8800
Memorial Sloan Kettering at Basking Ridge (Consent only)Basking RidgeNew Jersey07920
Alina Markova, MD
646-608-2342
Memorial Sloan Kettering Monmouth (Consent only)MiddletownNew Jersey07748
Alina Markova, MD
646-608-2342
Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)MontvaleNew Jersey07645
Alina K Markova, MD
646-608-2342
Memorial Sloan Kettering Cancer Center @ Commack (Consent only)CommackNew York11725
Alina K Markova, MD
646-608-2342
Memorial Sloan Kettering Westchester (Consent only)HarrisonNew York10604
Alina Markova, MD
646-608-2342
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Alina Markova, MD
646-608-2342
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)UniondaleNew York11553
Alina K Markova, MD, PhD
646-608-2342
University of Pittsburgh Medical Center (Data Collection Only)PittsburghPennsylvania15213
Annie Im, MD
[email protected]
412-864-7764

Find similar trials in Bethesda, MD

By research site
National Institute of Health (Data Collection AND Specimen Analysis)· Bethesda, MDMemorial Sloan Kettering at Basking Ridge (Consent only)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Consent only)· Middletown, NJMemorial Sloan Kettering Cancer Center @ Bergen (Consent only)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Commack (Consent only)· Commack, NYMemorial Sloan Kettering Westchester (Consent only)· Harrison, NY

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