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Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently affects children undergoing hematopoietic cell transplantation (HCT). As a result of intensive conditioning with chemotherapy with or without total body irradiation, and in the case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and suffering, increased utilization of opioid analgesics, and the need for intravenous or total parenteral nutritional support. Patients universally report OM as being the worst aspect of the HCT experience.A novel approach has been the use of larger light-emitting diode arrays to treat the at risk tissues from an extraoral approach, enabling exposure of the oral, oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and requiring only minimal patient cooperation. In this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy (LLLT) for the prevention of OM in children undergoing myeloablative HCT.
This is an open label, single treatment arm clinical pilot study. The study is targeted to enroll twelve evaluable patients
OBJECTIVES:
Primary
Secondary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Level Light Therapy (LLLT) | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Level Light Therapy | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The ability to maneuver and provide a new treatment for mucositis using (extraoral) LLLT | Several measures will be collected to evaluate the overall feasibility of providing daily extraoral LLLT for children undergoing HSCT including:
| 20 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient compliance with completing questionnaires | To address secondary the investigators, will calculate the following proportion: (number of times patients refused to complete one or both questionnaires) / (number of questionnaire completion timepoints), and place a 95% confidence interval on the proportion. | 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Treister, DMD,DMSc | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26982624 | Result | Treister NS, London WB, Guo D, Malsch M, Verrill K, Brewer J, Margossian S, Duncan C. A Feasibility Study Evaluating Extraoral Photobiomodulation Therapy for Prevention of Mucositis in Pediatric Hematopoietic Cell Transplantation. Photomed Laser Surg. 2016 Apr;34(4):178-84. doi: 10.1089/pho.2015.4021. Epub 2016 Mar 16. |
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| WHO Oral Toxicity Scale/ChIMES Instrument |
To address secondary aim, the investigator, will analyze the data from the WHO Oral Toxicity Scale and the ChIMES instrument using the analytic methods specifically prescribed for these standardized instruments. |
| 2 Years |
| Toxicity measured using CTC Version | 2 Years |
| Dose-limiting toxicity | 2 Years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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