Feasibility Study Evaluating Extraorally Delivered Low Level Light Therapy (LLLT) for the Prevention of Oropharyngeal Mucositis in Pediatric Patients Undergoing Myeloablative Hematopoietic Cell Transplantation

Status: Recruiting
Phase: N/A
Diagnosis: Pediatric Hematopoetic Stem Cell Transplant (HSCT)
NCT ID: NCT02119897 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-611


In this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy LLLT for the prevention of oropharyngeal mucositis OM in children undergoing myeloablative hematopoietic cell transplantation HCT.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Children's Hospital Boston

Overall PI:
Christine Duncan, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Nathaniel Treister, DMD, Brigham and Women's Hospital

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - Scheduled to undergo myeloablative conditioning followed by autologous or allogeneic hematopoietic cell transplantation at Boston Children's Hospital. - 4 years of age to 18 years of age. - WHO Oral Toxicity score of 0 at baseline evaluation (first day of conditioning). - Ability to understand and the willingness to sign a written informed consent document (for patients under the age of 18 this applies to parent/guardian) - Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document. Exclusion Criteria: - Treatment with oral LLLT within 4 weeks of HCT. - Participants may not be receiving any other agents intended for the prevention/management of mucositis (including palifermin and ice chips/cryotherapy). - WHO ≥1 at baseline evaluation.
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