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UVB Phototherapy Treatment of Oral Chronic GVHD

This study has been terminated.
(Low/slow accrual)
Dana-Farber Cancer Institute
Information provided by:
Brigham and Women's Hospital Identifier:
First received: September 8, 2006
Last updated: March 17, 2010
Last verified: March 2010
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.

Condition Intervention Phase
Oral Chronic Graft-Versus-Host Disease Procedure: Narrow-Band UVB Phototherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Narrow-Band UVB Phototherapy for Treatment of Oral Chronic Graft-versus-Host Disease

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD. [ Time Frame: 4 years ]

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

Estimated Enrollment: 40
Study Start Date: August 2006
Estimated Study Completion Date: August 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Narrow-Band UVB Phototherapy
    Performed either two or three times per week for a total of 24 treatments
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.

Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00374257

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Principal Investigator: Nathaniel S. Treister, DMD, DMSc Brigham and Women's Hospital
  More Information

Responsible Party: Nathaniel S. Treister, DMD, DMSc, Brigham and Women's Hospital Identifier: NCT00374257     History of Changes
Other Study ID Numbers: 06-054
Study First Received: September 8, 2006
Last Updated: March 17, 2010

Keywords provided by Brigham and Women's Hospital:

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases processed this record on August 23, 2017