UVB Phototherapy Treatment of Oral Chronic GVHD | NCT00374257

Studies
UVB Phototherapy Treatment of Oral Chronic GVHD

NCT00374257

Sponsor

Brigham and Women's Hospital

Status

Terminated

Last Update Posted

Dec 19, 2025Actual

Enrollment

11Actual

Phase

Phase 2

Conditions

Oral Chronic Graft-versus-host Disease

Interventions

Narrow-Band UVB Phototherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low/slow accrual

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Sep 8, 2006

First Submission Date that Met QC Criteria

Sep 8, 2006

First Posted Date

Sep 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2025

Last Update Posted Date

Dec 19, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nathaniel Simon Treister, Principal Investigator, Brigham and Women's HospitalPrincipal Investigator

Lead Sponsor

Brigham and Women's HospitalOTHER

Collaborators

Name	Class
Dana-Farber Cancer Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active intraoral NBUVB therapy	Experimental		Procedure: Narrow-Band UVB Phototherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Narrow-Band UVB Phototherapy	Procedure	Performed either two or three times per week for a total of 24 treatments	Active intraoral NBUVB therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD.		4 years

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the convenience, ease of use, tolerability and practicality of NB-UVB phototherapy in this patient population		4 years
to determine the effective maintenance doses/regimens in participants with good response for long-term management.		4 years

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nathaniel S. Treister, DMD, DMSc	Brigham and Women's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States
Dana-Farber Cancer Institute