Oral Chronic Graft-versus-host DiseasePhase 2NCT00374257
UVB Phototherapy Treatment of Oral Chronic GVHD
A Phase 2 study testing Narrow-Band UVB Phototherapy in people with Oral Chronic Graft-versus-host Disease, run by Brigham and Women's Hospital at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Oral Chronic Graft-versus-host Disease
- What is being tested?
- Narrow-Band UVB Phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- New immunomodulatory medications or increasing dosage of current immunomodulatory medications during the four weeks prior to study enrollment
- Concurrent extracorporeal photopheresis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Narrow-Band UVB Phototherapy for Treatment of Oral Chronic Graft-versus-Host Disease
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.
Read the 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.
- Conditions
- Oral Chronic Graft-versus-host Disease
- Being tested
- Narrow-Band UVB Phototherapy
- Keywords
- NB-UVB, cGVHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow-Band UVB PhototherapyProcedure or surgery
Performed either two or three times per week for a total of 24 treatments
| Study group | Role | What they receive |
|---|---|---|
| Active intraoral NBUVB therapy | Experimental | Not described Receives: Procedure: Narrow-Band UVB Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD.
Measured: 4 years
Secondary outcomes (2)
To evaluate the convenience, ease of use, tolerability and practicality of NB-UVB phototherapy in this patient population
Measured: 4 years
to determine the effective maintenance doses/regimens in participants with good response for long-term management.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Low/slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Chronic Graft-versus-host DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Nathaniel Simon Treister, Brigham and Women's Hospital
- Investigators
- Nathaniel S. Treister, DMD, DMSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374257
- Sponsor's protocol ID
- 06-054
- Status last verified
- Mar 2010
- First submitted
- 8 Sep 2006
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow-Band UVB Phototherapy for Treatment of Oral Chronic Graft-versus-Host Disease
- ClinicalTrials.gov ID
- NCT00374257
- Acronym / sponsor ID
- 06-054
- Conditions
- Oral Chronic Graft-versus-host Disease
- Keywords
- NB-UVB, cGVHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low/slow accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- Aug 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active intraoral NBUVB therapy | Experimental | Procedure: Narrow-Band UVB Phototherapy |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- New immunomodulatory medications or increasing dosage of current immunomodulatory medications during the four weeks prior to study enrollment
- Concurrent extracorporeal photopheresis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrow-Band UVB PhototherapyPerformed either two or three times per week for a total of 24 treatments | Procedure or surgery | Active intraoral NBUVB therapy |
Primary outcome
To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD.
Time frame: 4 years
2 secondary outcomes
To evaluate the convenience, ease of use, tolerability and practicality of NB-UVB phototherapy in this patient population
Time frame: 4 years
to determine the effective maintenance doses/regimens in participants with good response for long-term management.
Time frame: 4 years
Results and safety
The study was stopped early (reason given: Low/slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel S. Treister, DMD, DMSc principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Narrow-Band UVB Phototherapy in people with Oral Chronic Graft-versus-host Disease, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low/slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.