Feasibility Study Evaluating Extraorally Delivered Low Level Light Therapy (LLLT) for the Prevention of Oropharyngeal Mucositis in Pediatric Patients Undergoing Myeloablative Hematopoietic Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- The ability to maneuver and provide a new treatment for mucositis using (extraoral) LLLT
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The ability to maneuver and provide a new treatment for mucositis using (extraoral) LLLT
时间窗: 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)
次要结局
- Dose-limiting toxicity(2 Years)
- WHO Oral Toxicity Scale/ChIMES Instrument(2 Years)
- Patient compliance with completing questionnaires(2 Years)
- Toxicity measured using CTC Version(2 Years)
研究者
Nathaniel S. Treister, DMD, DMSc
Principal Investigator
Dana-Farber Cancer Institute