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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
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by:
Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE September 8, 2006
First Posted Date  ICMJE September 11, 2006
Last Update Posted Date March 19, 2010
Study Start Date  ICMJE August 2006
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD. [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2006)
To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2006)
  • To evaluate the convenience, ease of use, tolerability and practicality of NB-UVB phototherapy in this patient population
  • to determine the effective maintenance doses/regimens in participants with good response for long-term management.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE UVB Phototherapy Treatment of Oral Chronic GVHD
Official Title  ICMJE Narrow-Band UVB Phototherapy for Treatment of Oral Chronic Graft-versus-Host Disease
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Oral Chronic Graft-Versus-Host Disease
Intervention  ICMJE Procedure: Narrow-Band UVB Phototherapy
Performed either two or three times per week for a total of 24 treatments
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: September 8, 2006)
40
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2010
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00374257
Other Study ID Numbers  ICMJE 06-054
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nathaniel S. Treister, DMD, DMSc, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Dana-Farber Cancer Institute
Investigators  ICMJE
Principal Investigator: Nathaniel S. Treister, DMD, DMSc Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP