Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
Study NCT ID:
NCT05335434
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2022-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of severe Oral Mucositis', 'timeFrame': '20 Days', 'description': 'Defined as the total number of days between day 0 and day +20 on which severe (WHO grade 3 or 4) OM was reported'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Myeloablative Allogeneic Hematopoietic Cell Transplantation (HCT)', 'Intraoral Photobiomodulation Therapy', 'Oral Mucositis', 'Mucosal Ulcer'], 'conditions': ['Myeloablative Allogeneic Hematopoietic Cell Transplantation', 'Intraoral Photobiomodulation Therapy', 'Oral Mucositis', 'Mucosal Ulcer']}, 'descriptionModule': {'briefSummary': 'This is a single center pilot study evaluating intraoral photobiomodulation for the prevention of oral mucositis in patients undergoing myeloablative allogeneic hematopoietic cell transplantation (alloHCT). Patients who are planned for alloHCT will receive daily intraoral photobiomodulation therapy (PBMT) using a novel LED device.\n\nThe name of the study device involved in this study is:\n\n\\- THOR LX2.3 with LED Lollipop', 'detailedDescription': 'As part of a transplant procedure patients will receive chemotherapy in a conditioning regimen in preparation of alloHCT as well as immunosuppressive medications to help prevent graft-versus-host disease ("GVHD prophylaxis"). Together, these treatments will put patients at risk for developing side effects. A common side effect is oral mucositis (OM), in which mouth sores develop making eating and speaking difficult and painful.\n\nPhotobiomodulation therapy (PBMT) is a light-based therapy that reduces inflammation and enhances wound healing. PBMT delivered inside the mouth has been shown to reduce OM in patients undergoing alloHCT.\n\nThe name of the study device involved in this study is:\n\n\\- THOR LX2.3 with LED Lollipop\n\nThis research study is a Pilot Study, which is the first time that investigators are examining this LED based intraoral PBMT.\n\nThe U.S. Food and Drug Administration (FDA) has not approved PBMT for this specific disease but it has been approved for other uses.\n\nThe research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations.\n\nParticipants will receive study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first.\n\nIt is expected that about 20 people will take part in this research study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned to undergo myeloablative allogeneic HCT using FluBu4 conditioning and Tac-Mtx GVHD prophylaxis.\n* Age ≥18 years.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have had treatment with intraoral PBMT within four weeks of admission for HSCT.\n* Participants who have a history of radiation therapy to the head and neck.\n* Participants who have a history of photosensitivity or underlying disease with known photosensitivity.\n* Participants who are planned to receive palifermin for OM prevention.'}, 'identificationModule': {'nctId': 'NCT05335434', 'briefTitle': 'Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Single Center Pilot Study of Intraoral Photobiomodulation Therapy for the Prevention of Oral Mucositis in Patients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation', 'orgStudyIdInfo': {'id': '22-036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT', 'description': 'The research study procedures include: screening for eligibility and study treatment including daily PBMT and clinical evaluations. Participants will receive the study treatment daily from the start of conditioning chemotherapy to day +20, or discharge (if you are able to be discharged from the hospital prior to day +20), whichever occurs first\n\n-THOR LX2.3 with LED Lollipop', 'interventionNames': ['Device: THOR LX2.3 with LED Lollipop']}], 'interventions': [{'name': 'THOR LX2.3 with LED Lollipop', 'type': 'DEVICE', 'description': 'The intraoral PBMT device will be placed inside of the mouth to deliver the therapeutic light. Each treatment is approximately 2-3 minutes in duration. PBMT will be administered daily starting from the start of conditioning through day +20, or discharge if prior to day +20, with 27 consecutive days defined as a maximum PBMT treatment duration', 'armGroupLabels': ['INTRAORAL PBMT IN PATIENTS UNDERGOING alloHCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kentaro Ikeda, DDS, DMSc', 'role': 'CONTACT', 'email': 'kikeda4@bwh.harvard.edu', 'phone': '617-732-6570'}, {'name': 'Kentaro Ikeda, DDS, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nathaniel S. Treister, DMD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Kentaro Ikeda, DDS,MPH', 'role': 'CONTACT', 'email': 'kikeda4@bwh.harvard.edu', 'phone': '617-732-6570'}], 'overallOfficials': [{'name': 'Kentaro Ikeda, DDS, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Nathaniel S. Treister, DMD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'Contact the Partners Innovations team at http://www.partners.org/innovation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'THOR Photomedicine Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kentaro Ikeda, DDS, MPH', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}