MedDataX Logo

UVB Phototherapy Treatment of Oral Chronic GVHD

NCT ID: NCT00374257

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Chronic Graft-versus-host Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

NB-UVB cGVHD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active intraoral NBUVB therapy

Group Type EXPERIMENTAL

Narrow-Band UVB Phototherapy

Intervention Type PROCEDURE

Performed either two or three times per week for a total of 24 treatments

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Narrow-Band UVB Phototherapy

Performed either two or three times per week for a total of 24 treatments

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nathaniel Simon Treister

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nathaniel S. Treister, DMD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06-054

Identifier Type: -

Identifier Source: org_study_id