Photobiomodulation Therapy for the Prevention of Mucositis in Pediatric Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluate the feasibility and acceptability of using PBM in pediatric oncology patients.
研究概览
简要总结
The goal of this clinical trial is to learn if light therapy can prevent mouth sores in children with cancer. The main questions it aims to answer are:
Is it reasonable and acceptable to provide light therapy for children with cancer?
Does light therapy prevent mouth sores related to medical treatment?
Researchers will compare children who do not receive light therapy to children who do receive light therapy during the clinical trial to see if light therapy helps to prevent mucositis.
Participants will:
- Complete a survey.
- Have picture taken of their mouth to look for mouth sores.
- Receive light therapy every day while admitted to the hospital on the cancer unit or while admitted to an alternate unit, and continue to receive light therapy in the home setting until they reach 8 days after the start of their chemotherapy cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current and new diagnosis patients consented upon admission if deemed eligible
- •Admitted to CW oncology/BMT inpatient unit, PICU, or West 5
- •Chemotherapy regimen: Methotrexate ≥5 g/m2 (or ≥1 g/m2 if Trisomy 21) OR Anthracycline ≥60 mg/m2
- •Able to speak and understand English or Spanish
排除标准
- •Patients admitted on BMT service
- •Patients currently experiencing mucositis with a CTCAE grade 4 oral mucositis or higher
研究组 & 干预措施
Control Arm
Prospective data review of patients who did not receive light therapy
Prevention Arm
Prospective data review of patients who did receive light therapy
干预措施: Photobiomodulation for prevention arm (Device)
Exploratory Arm
Prospective review of patients with Trisomy 21 who did receive light therapy
干预措施: Photobiomodulation for exploratory arm (Device)
结局指标
主要结局
Evaluate the feasibility and acceptability of using PBM in pediatric oncology patients.
时间窗: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
This will be assessed through a questionnaire completed by the RN administering the PBM therapy and will focus on the patient's tolerance level rated on a numerical scale, the nurse's perception of feasibility, and length of treatment in minutes.
Evaluate the feasibility of using PBM in pediatric oncology patients.
时间窗: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Feasibility of PBM will be assessed by the RN completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the ease of delivery of PBM therapy. A score of ≥3 indicates that the PBM therapy was feasible.
Evaluate the acceptability of using PBM in pediatric oncology patients.
时间窗: From date of enrollment until date of last PBM treatment, assessed up to 2 years.
Acceptability of PBM will be assessed by the patient/caregiver completing a survey using a 5-point Likert scale (5 being strongly agree and 1 being strongly disagree) to evaluate the patient's tolerance of the treatment. A score of ≥3 indicates acceptability of PBM therapy.
次要结局
- Evaluate the effectiveness of using PBM based on mucositis onset(From date of enrollment until date of last PBM treatment, assessed up to 2 years.)
- Evaluate the effectiveness of using PBM based on mucositis severity.(From date of enrollment until date of last PBM treatment, assessed up to 2 years.)
- Evaluate the effectiveness of using PBM based on mucositis duration.(From date of enrollment until date of last PBM treatment, assessed up to 2 years.)
- Evaluate the effectiveness of using PBM based on length of stay.(From date of enrollment until date of last PBM treatment, assessed up to 2 years.)
- Evaluate the effectiveness of using PBM based on narcotic usage.(From date of enrollment until date of last PBM treatment, assessed up to 2 years.)
- Evaluate the effectiveness of using PBM based on nutritional support.(From date of enrollment until date of last PBM treatment, assessed up to 2 years.)
- Evaluate the effectiveness of using PBM based on pain score.(From date of enrollment until date of last PBM treatment, assessed up to 2 years.)
- Evaluate the effectiveness of using PBM based on MBI CLABSI rate.(From date of enrollment until date of last PBM treatment, assessed up to 2 years.)
- Evaluate the effectiveness of using PBM based on Glutamine administration.(From date of enrollment until date of last PBM treatment, assessed up to 2 years.)
- Evaluate the effectiveness of using PBM in reducing the incidence and severity of mucositis in pediatric oncology patients receiving chemotherapy.(From date of enrollment until date of last PBM treatment, assessed up to 2 years.)
研究者
Elissa Shulta
Principal Investigator
Medical College of Wisconsin