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UVB Phototherapy Treatment of Oral Chronic GVHD

Primary Purpose

Oral Chronic Graft-Versus-Host Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Narrow-Band UVB Phototherapy
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Chronic Graft-Versus-Host Disease focused on measuring NB-UVB, cGVHD

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 8, 2006
Last Updated
March 17, 2010
Sponsor
Brigham and Women's Hospital
Collaborators
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00374257
Brief Title
UVB Phototherapy Treatment of Oral Chronic GVHD
Official Title
Narrow-Band UVB Phototherapy for Treatment of Oral Chronic Graft-versus-Host Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Why Stopped
Low/slow accrual
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Chronic Graft-Versus-Host Disease
Keywords
NB-UVB, cGVHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Narrow-Band UVB Phototherapy
Intervention Description
Performed either two or three times per week for a total of 24 treatments
Primary Outcome Measure Information:
Title
To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
To evaluate the convenience, ease of use, tolerability and practicality of NB-UVB phototherapy in this patient population
Time Frame
4 years
Title
to determine the effective maintenance doses/regimens in participants with good response for long-term management.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel S. Treister, DMD, DMSc
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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UVB Phototherapy Treatment of Oral Chronic GVHD

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