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

Phase 2
4 Years
Not Enrolling
Oral Chronic Graft-Versus-Host Disease

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Trial Information

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Nathaniel S. Treister, DMD, DMSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital


United States: Institutional Review Board

Study ID:




Start Date:

August 2006

Completion Date:

August 2010

Related Keywords:

  • Oral Chronic Graft-Versus-Host Disease
  • NB-UVB
  • cGVHD
  • Graft vs Host Disease



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115