UVB Phototherapy Treatment of Oral Chronic GVHD

Study Overview
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Brief Summary
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The purpose of this trial is to find out how effective Narrow Band-Ultraviolet Light B (NB-UVB) phototherapy is in treating oral cGVHD. NB-UVB Phototherapy involves exposing the inside of the mouth to light of a particular spectrum (a specific wavelength of light, 311nm) of the ultraviolet band, called NB-UVB. It is known that narrow band ultraviolet light therapy can improve symptoms in patients with skin chronic GVHD.

Detailed Description
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At the first visit the following information will be collected about the participant: original diagnosis, the date and type of transplant, transplant conditioning regimen, cGVHD prophylaxis regimen, the time when oral cGVHD was first noticed, specific treatments for oral cGVHD, and any current medications. At each visit, and before the participant begins phototherapy treatment, they will answer a series of questions asking about how their mouth feels and what they are able to eat. A clinical examination of the mouth will be performed and recorded and photographs will be taken of the inside of the mouth. Participants will then receive phototherapy treatment. This will take approximately three minutes and will involve opening the mouth and closing the eyes. Following phototherapy, the participant will be asked several questions on how they tolerated the treatment. Phototherapy treatments will be done two or three times per week for a total of 24 treatments. After each treatment, if the participant has not experienced any discomfort, the phototherapy dose will be increased following a specific protocol. After 24 treatments the participant will have the option to continue phototherapy treatments.

Official Title
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Narrow-Band UVB Phototherapy for Treatment of Oral Chronic Graft-versus-Host Disease

Conditions
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Oral Chronic Graft-Versus-Host Disease

Intervention / Treatment
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* Procedure: Narrow-Band UVB Phototherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with oral chronic graft-versus-host disease 4 years of age or older Stable cGVHD medication regimen for the four weeks prior to study enrollment Exclusion Criteria: New immunomodulatory medications or increasing dosage of current immunomodulatory medications during the four weeks prior to study enrollment Concurrent extracorporeal photopheresis.

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Narrow-Band UVB Phototherapy|Performed either two or three times per week for a total of 24 treatments|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD. |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the convenience, ease of use, tolerability and practicality of NB-UVB phototherapy in this patient population |  | 4 years | 
| to determine the effective maintenance doses/regimens in participants with good response for long-term management. |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NB-UVB, cGVHD