Prevention of Oral Mucositis in Children and Adolescents Undergoing Hematopoietic Stem Cell Transplant Using Photobiomodulation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Efficacy of Photo Biomodulation Therapy (PBM) in Reducing Oral Mucositis (OM) in Children and Adolescents at Risk for Grade 3 OM Undergoing an Allogeneic Hematopoietic Cell Transplant (HCT).
研究概览
简要总结
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.
详细描述
Children, adolescents and young adults admitted for an allogeneic HCT and those determined by the transplant team to be at risk for grade 3 oral mucositis will be eligible to receive PBM (34 x 660nm 10mW, 35 x 850nm 30mW: 1390 mW total power output) at an irradiance of 50mW/cm2. The PBM treatment will be administered via the THOR Model LX2M unit.
After low light therapy consent, participants will be offered the opportunity to receive a play-based preparation. Those who elect to receive this child life preparation will be scheduled to meet with a trained certified child life specialist (CCL) prior to admission. The play-based preparation will incorporate age and developmentally appropriate explanations of the non-invasive procedure and will be adapted to each patient's psychosocial and cognitive developmental needs.
Observation and treatment will begin the first day of conditioning (plus/minus 2 days). Those undergoing an allogeneic HCT will have treatment daily until Day +20 or engraftment (ANC ≥ 500 for two consecutive days). For those undergoing an autologous transplant, treatment will continue until engraftment (ANC ≥ 500 for two consecutive days) or until the patient is without mucositis for two consecutive days.
The PBM will be administered extra-oral and intra-oral by trained research staff. Direct aim of the laser into the eye will be avoided and safety spectacles will be used with laser therapy. The safety spectacles will be prescribed according to age, with the adjustable Ibis Infant eye protection for patients less than 1 year of age and the adjustable kids laser safety googles for the young child. Patients, staff, and observers will wear laser safety glasses while PBM is in use.
The parent may hold the device in place with assistance from the trained persons. After the initial LLLT treatment, a parent-reported satisfaction survey will be administered via paper questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No age limitation
- •To be admitted for an allogeneic hematopoietic cell transplant
- •All eligible autologous hematopoietic cell transplant, at risk for grade 3 mucositis per transplant service secondary to conditioning regimen or previous history of grade 3 mucositis
- •Dental exam prior to admission, as per preadmission criteria
- •Willingness of research participant to provide assent/consent and parent/ legal guardian/representative to give written informed consent.
排除标准
- •Deemed by transplant team as unable to participate
- •Known sensitivity to light therapy
- •Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
- •CAR-Tcell Protocol
结局指标
主要结局
Efficacy of Photo Biomodulation Therapy (PBM) in Reducing Oral Mucositis (OM) in Children and Adolescents at Risk for Grade 3 OM Undergoing an Allogeneic Hematopoietic Cell Transplant (HCT).
时间窗: Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)
It was estimated from a retrospective review of HCT patients that 71% of participants undergoing a HCT developed grade 3 mucositis. With an estimated clinically meaningful effect size of 20% for PBM, the estimated percentage of PBM participant to develop grade 3 mucositis was set at 51%. An interim analysis was conducted after the enrollment of 40 participants.
Feasibility of Photo Biomodulation Therapy (PBM) in Reducing Oral Mucositis (OM) in Children and Adolescents at Risk for Grade 3 OM Undergoing an Allogeneic Hematopoietic Cell Transplant (HCT).
时间窗: Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500)
Feasibility was assessed through the number of successful treatments (957) administered by the total number of attempted treatments (1023), providing the percentage of successful treatment administered. Daily treatment included 6 sites of PBM application, with application documented as receiving all 6 applications, in part treatment (at least one to five sites) or no treatment. A successful treatment was defined as successfully administered to 4 or more sites. Reasons for partial or no treatment was documented. Criteria for feasibility was 75%.
次要结局
- Days of Hospitalization Between Groups(From the time of admission to discharge)
- Assess the Severity of Mucositis Grade 1-3 and Duration for Each Patient Treated With PBM Compared to Matched Controls(Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500))
- Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control.(Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500))
- Compare the Mucositis Grade and Duration Between Those Who Received PBM and Match Control(Daily assessment from day 1 of conditioning to 20 days after transplant or engraftment (2 consecutive days of an Absolute Neutrophil Count (ANC)>500))