Trial Title:
A Study of Photobiomodulation (PBM) Therapy in People with Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
NCT ID:
NCT05675930
Condition:
Graft-Versus-Host Disease
GVHD
Undefined
Conditions: Official terms:
Bronchiolitis Obliterans Syndrome
Graft vs Host Disease
Conditions: Keywords:
Graft-Versus-Host Disease
GVHD
Chronic Graft Versus Host Disease Oral
PhotobiomoduLatIon
Memorial Sloan Kettering Cancer Center
22-271
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a phase 2, double-blind, randomized (1:1 ratio) study
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
Masking description:
Double-blind
Intervention:
Intervention type:
Device
Intervention name:
Photobiomodulation Therapy
Description:
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
Arm group label:
Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)
Other name:
PBM Therapy
Other name:
Thor LX2.3 system device
Intervention type:
Other
Intervention name:
Placebo sham device
Description:
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
Arm group label:
Adult and pediatric patients who received a placebo treatment
Other name:
Thor LX2.3 sham device setting
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
4 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Institute of Health (Data Collection AND Specimen Analysis)
Address:
City:
Bethesda
Zip:
20892
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jacqueline Mays, DDS, MHSc, PhD
Phone:
(301) 496-8800
Email:
jacqueline.mays@nih.gov
Facility:
Name:
Memorial Sloan Kettering at Basking Ridge (Consent only)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alina Markova, MD
Phone:
646-608-2342
Facility:
Name:
Memorial Sloan Kettering Monmouth (Consent only)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alina Markova, MD
Phone:
646-608-2342
Facility:
Name:
Memorial Sloan Kettering Cancer Center @ Bergen (Consent only)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alina K Markova, MD
Phone:
6466082342
Facility:
Name:
Memorial Sloan Kettering Cancer Center @ Commack (Consent only)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alina K Markova, MD
Phone:
6466082342
Facility:
Name:
Memorial Sloan Kettering Westchester (Consent only)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alina Markova, MD
Phone:
6466082342
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alina Markova, MD
Phone:
646-608-2342
Facility:
Name:
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alina K Markova, MD, PhD
Phone:
6466082342
Facility:
Name:
Memorial Sloan Kettering Westchester (Consent only)
Address:
City:
West Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alina Markova, MD
Phone:
646-608-2342
Facility:
Name:
University of Pittsburgh Medical Center (Data Collection Only)
Address:
City:
Pittsburg
Zip:
15213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Annie Im, MD
Phone:
412-864-7764
Email:
imap@upmc.edu
Start date:
December 22, 2022
Completion date:
December 22, 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05675930
http://www.mskcc.org
