UVB Phototherapy Treatment of Oral Chronic GVHD

This study has been terminated.
(Low/slow accrual)
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00374257
First received: September 8, 2006
Last updated: March 17, 2010
Last verified: March 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • to determine the effective maintenance doses/regimens in participants with good response for long-term management. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

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.
  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374257

Locations
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
Investigators
Principal Investigator: Nathaniel S. Treister, DMD, DMSc Brigham and Women's Hospital
  More Information

No publications provided

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
Study First Received: September 8, 2006
Last Updated: March 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
NB-UVB
cGVHD

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

ClinicalTrials.gov processed this record on October 19, 2014