UVB Phototherapy Treatment of Oral Chronic GVHD

Oral Chronic Graft-Versus-Host Disease Clinical Trial

Official title:

Narrow-Band UVB Phototherapy for Treatment of Oral Chronic Graft-versus-Host Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00374257
• Other study ID #: 06-054
• Status: Terminated
• Phase: Phase 2
• First received: September 8, 2006
• Last updated: March 17, 2010
• Start date: August 2006
• Est. completion date: August 2010

Study information

• Verified date: March 2010
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Oral Chronic Graft-Versus-Host Disease

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD.		4 years	No
Secondary	To evaluate the convenience, ease of use, tolerability and practicality of NB-UVB phototherapy in this patient population		4 years	Yes
Secondary	to determine the effective maintenance doses/regimens in participants with good response for long-term management.		4 years	No