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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-22

Study Completion Date

2026-12-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Graft-Versus-Host Disease GVHD Undefined

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a phase 2, double-blind, randomized (1:1 ratio) study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Double-blind

Study Groups

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Adult and pediatric patients who received an allogeneic stem cell transplant (allo-HCT)

Participants are Allo-HCT recipients

Group Type ACTIVE_COMPARATOR

Photobiomodulation Therapy

Intervention Type 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

Adult and pediatric patients who received a placebo treatment

Participants are Allo-HCT recipients

Group Type PLACEBO_COMPARATOR

Placebo sham device

Intervention Type 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

Interventions

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Photobiomodulation Therapy

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

Intervention Type DEVICE

Placebo sham device

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

Intervention Type OTHER

Other Intervention Names

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PBM Therapy Thor LX2.3 system device Thor LX2.3 sham device setting

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No