Effect of Low-level Laser Therapy on Inflammatory Mediators Release During Chemotherapy-induced Oral Mucositis: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Severity of Oral Mucositis
研究概览
简要总结
The aim of the study is to evaluate the effect of low-level laser therapy (LLLT) on the severity of oral mucositis (OM) and inflammatory mediators (pro- and anti-inflammatory cytokines, metalloproteinases and growth factors) levels in saliva and blood; furthermore, analyze the effect of LLLT in product modulation of oxidative stress and cell damage from the oral mucosa transplant patients.
详细描述
This is a randomized clinical trial in which the proposed analysis will be performed from saliva samples of patients transplanted bone marrow, divided into two different groups (control and laser) and collected at different times during the hospitalization of the patient. the group laser receive prophylactic laser therapy, in order to evaluate the effects of LLLT in inflammatory mediators (cytokines pro- and anti-inflammatory) as well as their effect on modulation of oxidative stress products and cell damage (nitric oxide, myeloperoxidase, interleukin-8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Schedule to receive myeloablative conditioning regimens using chemotherapy; oral mucosa lining intact on the first day of the conditioning regimen;
排除标准
- •Patients who presented with oral oral ulceration or erosion, active oral, viral, bacterial, or fungal infections on admission, or active oral bleeding which was uncontrollable during laser therapy or had required oral tracheal intubation during hospitalization in the HSCT Unit.
结局指标
主要结局
Severity of Oral Mucositis
时间窗: On day of the transplant (D0), on seventh day after the transplant (D7) and discharge of the patient (HD) or until day 20 (D+20).
A trained clinical member of the team who was blind to the randomization allocation scores the degree of OM, during the hospitalization, in accordance to the World Health Organization (WHO) mucositis scale as follow: grade 0, no signs or symptoms; grade 1, painless ulcers, erythema, or mild soreness; grade 2, painful erythema, edema, or ulceration but the patient is able to eat; grade 3, mucosal damage and the patient is able to ingest only liquids; and grade 4, severe mucosa damage and the patient requires parenteral or enteral support.
次要结局
- Level of Inflammatory Mediators(The samples were collected at three different moments of treatment: at the time of admission (AD), on the seventh day after transplantation (D+7), and on the day of discharge (with neutrophil >0.5 × 109/l for two consecutive days) (HD).)
研究者
Geisa Badauy Lauria Silva
Principal investigator
Universidade Federal de Goias