Assessment of Efficacy of LightWalker (Nd:Yag, Er:Yag) Laser Therapy on Incidence, Severity and Duration of Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT). Prospective Randomized Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Duration of oral mucositis
研究概览
简要总结
Oral mucositis (OM) is a common and debilitating adverse effect of conditioning regimens in patients undergoing hematopoietic cell transplantation (HCT). It is treated symptomatically with pain relief medications. The use of low-level laser therapy (LLLT) to prevent tissue damage has been postulated for almost forty years, however, there are only a few reports concerning old generation lasers in mucositis prophylaxis in HCT recipients. Here we hypothesized, that a new generation LLLT (Nd: YAG Fotona LightWalker®) laser may be an effective prophylaxis in shortening and reducing the severity of this complication.
详细描述
This clinical trial is a prospective, randomized open-label study. All patients qualified to hematopoietic stem cell transplantation will be informed about possibility of taking part in this study. Patients who meet the inclusion criteria will be enrolled and randomized into two groups.
Patients in the first group will receive standard supportive treatment. Patients in the second group, except for the supportive treatment (as in the first group), will additionally receive prophylactic laser therapy of oral mucosa during high-dose chemotherapy conditioning before HSCT. Patients will undergo laser treatment daily from the first day of conditioning regimen till the second day after stem cell transfusion. The procedure will be carried out by trained staff at the bedside.
Severity of oral mucositis and pain will be measured in both groups on days 0, 4, 7, 11, 14, 18 and 21 after HSCT.
Severity of oral mucositis will be assessed according to five-point WHO scale Pain intensity will be measured on the basis of ten-point NRS scale.
In addition, the need for opioid analgesics and total parenteral nutrition will be evaluated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written, informed consent for participation in the study
- •oral sanation
- •myeloablative conditioning
排除标准
- •lack of patient's consent
- •pathological lesions in oral cavity on the first day of conditioning regimen
- •renal failure
- •active infection
结局指标
主要结局
Duration of oral mucositis
时间窗: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Duration of oral mucositis duration in days measured in both groups
Severity of oral mucositis
时间窗: First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation
Evaluation of pain according to NRS scale
次要结局
- Need for opioid analgesics calculated(First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation)
- Length of most severe pain(First day of conditioning chemotherapy till 21 st day post hematopoietic stem cell transplantation)