Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-02-25 @ 6:57 PM
Study NCT ID:
NCT00374257
Status:
TERMINATED
Last Update Posted:
2025-12-19
First Post:
2006-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UVB Phototherapy Treatment of Oral Chronic GVHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Low/slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2006-09-08', 'studyFirstSubmitQcDate': '2006-09-08', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To clinically evaluate the treatment efficacy of NB-UVB phototherapy in the management of oral cGVHD.', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'To evaluate the convenience, ease of use, tolerability and practicality of NB-UVB phototherapy in this patient population', 'timeFrame': '4 years'}, {'measure': 'to determine the effective maintenance doses/regimens in participants with good response for long-term management.', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NB-UVB', 'cGVHD'], 'conditions': ['Oral Chronic Graft-versus-host Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '* 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.\n* 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.\n* 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.\n* After 24 treatments the participant will have the option to continue phototherapy treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with oral chronic graft-versus-host disease\n* 4 years of age or older\n* Stable cGVHD medication regimen for the four weeks prior to study enrollment\n\nExclusion Criteria:\n\n* New immunomodulatory medications or increasing dosage of current immunomodulatory medications during the four weeks prior to study enrollment\n* Concurrent extracorporeal photopheresis.'}, 'identificationModule': {'nctId': 'NCT00374257', 'briefTitle': 'UVB Phototherapy Treatment of Oral Chronic GVHD', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Narrow-Band UVB Phototherapy for Treatment of Oral Chronic Graft-versus-Host Disease', 'orgStudyIdInfo': {'id': '06-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active intraoral NBUVB therapy', 'interventionNames': ['Procedure: Narrow-Band UVB Phototherapy']}], 'interventions': [{'name': 'Narrow-Band UVB Phototherapy', 'type': 'PROCEDURE', 'description': 'Performed either two or three times per week for a total of 24 treatments', 'armGroupLabels': ['Active intraoral NBUVB therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Nathaniel S. Treister, DMD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nathaniel Simon Treister', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}