UVB Phototherapy Treatment of Oral Chronic GVHD

Mass General Brigham

Status and phase

Terminated

Phase 2

Conditions

Oral Chronic Graft-versus-host Disease

Treatments

Procedure: Narrow-Band UVB Phototherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00374257

06-054

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

4+ years old

Volunteers

No 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.