Clinical trial NCT00374257: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Oral Chronic Graft-Versus-Host Disease
Keywords: NB-UVB
cGVHD
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2006-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD.
timeFrame: 4 years
Secondary outcomes:
measure: To evaluate the convenience, ease of use, tolerability and practicality of NB-UVB phototherapy in this patient population
timeFrame: 4 years
measure: to determine the effective maintenance doses/regimens in participants with good response for long-term management.
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Nathaniel S. Treister, DMD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: