At a glance
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Prevention of Oral Mucositis in Children and Adolescents Undergoing Hematopoietic Stem Cell Transplant Using Photobiomodulation Therapy
In Brief
A clinical study evaluating Photobiomodulation Therapy (PBM), Pain and Oral Function Assessment, and 1 other intervention for Oral Mucositis. Completed, enrolled 43 participants across 1 site.
Detailed Summary
Oral mucositis is a significant and common toxicity experienced by patients who receive high-dose chemotherapy as a preparatory regimen for a hematopoietic cell transplant (HCT). Furthermore, oral mucositis has been reported as the single most debilitating side effect reported by patients undergoing HCT. The incidence of HCT mucositis among adults is estimated to range between 76% and 89%; however, comparisons are difficult due to variability in patient ages, treatments and criteria for scoring oral mucositis. The use of intra-oral photobiomodulation (PBM) therapy in adult patients after the development of oral mucositis is well documented and now included in the international mucositis guidelines, with limited evidence in pediatrics. This study will build evidence for the incorporation of extra-oral PBM therapy into daily nursing care of children and adolescents undergoing HCT. This intervention has potential in providing evidence for efficacy in the prevention and treatment of oral mucositis, the single most debilitating side effect reported by patients undergoing HCT. Primary Objective: * To evaluate feasibility and efficacy of photobiomodulation therapy (PBM) in reducing oral mucositis in children and adolescents at risk for grade 3 oral mucositis undergoing an allogeneic hematopoietic cell transplant (HCT). Secondary Objective: * To compare clinical manifestations associated with the development of oral mucositis between those treated with daily PBM and a matched control. Clinical factors to include: grade and duration or oral mucositis. Exploratory Objective: * To evaluate efficacy of photobiomodulation therapy in autologous patients at risk for grade 3 oral mucositis compared to matched control. * To evaluate utilization of play-based procedural preparation and treatment feasibility and parental satisfaction.
Study Details
Timeline
Interventions
The PBM will be delivered through application of the LED Cluster Probe externally to the right external buccal, left external buccal, mid face with mouth open and submandibular and left/right cervical. Patients who develop an oral lesion, intra-oral directed therapy will be administered with the dental light probe. For patients that can tolerate, an intraoral probe will deliver light directly onto the oral mucosa, this will then replace the mid face application with mouth open. Each laser application will be timed at 60 seconds.
After the 6-minute laser/ treatment session the child and parent will complete the mucositis evaluation scale on paper or ipad which includes self-report oral function specific to ability to swallow, eat and drink, as well as the patient's self-reported need for medication specific to mouth pain.
A parent-reported satisfaction survey will be administered via paper questionnaire after the initial LLLT treatment. Parent satisfaction will be reported by parents on a 5-point Likert scale to questions adapted from a parent satisfaction survey used in a study regarding child life services in pediatric imaging.