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临床试验/NCT05175222
NCT05175222已完成不适用

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

Medical University of Gdansk2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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