Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374257
Status:
TERMINATED
Last Update Posted:
2010-03-19
First Post:
2006-09-08
Brief Title:
UVB Phototherapy Treatment of Oral Chronic GVHD
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Narrow-Band UVB Phototherapy for Treatment of Oral Chronic Graft-versus-Host Disease
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lowslow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None