Oral Chronic Graft-versus-host Disease
Conditions
Keywords
NB-UVB, cGVHD
Brief summary
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
* 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.
Interventions
PROCEDURENarrow-Band UVB Phototherapy
Performed either two or three times per week for a total of 24 treatments
Sponsors
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD. | 4 years |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed