Oropharyngeal Mucositis, Myeloablative Hematopoietic Cell Transplantation, Low Level Light Therapy
Conditions
Keywords
Oropharyngeal Mucositis, Myeloablative Hematopoietic Cell Transplantation, Low Level Light Therapy
Brief summary
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.
Detailed description
This is an open label, single treatment arm clinical pilot study. The study is targeted to enroll twelve evaluable patients OBJECTIVES: Primary * Determine the feasibility of providing extraoral LLLT for prevention of OM in pediatric patients undergoing HCT Secondary * Determine the feasibility of collecting data using the WHO Oral Toxicity Scale and ChIMES in pediatric patients undergoing myeloablative HCT who are treated with extraoral LLLT for prevention of OM * Evaluate the safety and tolerability of extraoral LLLT for prevention of OM in pediatric patients undergoing myeloablative HCT
Interventions
DEVICELow Level Light Therapy
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 25 Years
Healthy volunteers
No
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 25 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The ability to maneuver and provide a new treatment for mucositis using (extraoral) LLLT | 20 Days | Several measures will be collected to evaluate the overall feasibility of providing daily extraoral LLLT for children undergoing HSCT including: * Accessibility and maneuverability of the LLLT device (transportation from storage site to hospital room, device weight) * Administration of LLLT (device settings, positioning of device, delivery of therapy) * Patient tolerability (level of comfort during treatments, compliance with daily therapy * Proportion of days with therapy administered, as evidence by data submitted (goal is ≥75%) * Ability to enroll at least 5 patients within the first 3 months (this pertains to the feasibility of study conduct, and not to the feasibility of the therapeutic approach) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient compliance with completing questionnaires | 2 Years | 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. |
| WHO Oral Toxicity Scale/ChIMES Instrument | 2 Years | 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. |
| Toxicity measured using CTC Version | 2 Years | — |
| Dose-limiting toxicity | 2 Years | — |
Countries
United States
Outcome results
None listed