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UVB Phototherapy Treatment of Oral Chronic GVHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00374257
Recruitment Status : Terminated (Low/slow accrual)
First Posted : September 11, 2006
Last Update Posted : March 19, 2010
Information provided by:

Study Description
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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : August 2006
Primary Completion Date : September 2008
Estimated Study Completion Date : August 2010

Arms and Interventions

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

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00374257     History of Changes
Other Study ID Numbers: 06-054
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: March 19, 2010
Last Verified: March 2010

Keywords provided by Brigham and Women's Hospital:

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases