Narrow-Band UVB Phototherapy for Treatment of Oral Chronic Graft-versus-Host Disease
- 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD.
4 years
No
Nathaniel S. Treister, DMD, DMSc
Principal Investigator
Brigham and Women's Hospital
United States: Institutional Review Board
06-054
NCT00374257
August 2006
August 2010
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |