Laser Therapy Prevents Mucositis Oral in Patients Undergoing to Chemotherapy for Bone Marrow Transplantation? A Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Incidence of Oral Mucositis
研究概览
简要总结
Setting: Oral mucositis is a very common complication of cancer treatment, accounting, often at increased risk for infections and even the interruption of treatment, interfering with the prognosis of the disease. The low intensity laser therapy has been proposed as an alternative for the treatment and prevention of this side effect, with good results in terms of clinical and functional, speeding up the process of wound healing and reducing pain.
Objective: To evaluate the effectiveness of using low power laser in the prevention of oral mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow transplantation.
Methods: There will be a Clinical Trial Randomized, double-blind study to evaluate the effectiveness of using low power laser in the prevention of oral mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow transplantation. Participate in the study, patients who are in the condition mentioned above accepting participate and have aged over 18. Will be excluded from the study patients who have autoimmune disease, which present sensitivity to laser or who have already started treatment for oral mucositis prior to this study.The study variables are:-independent variable: whether or not the red laser of low power-dependent variables: oral mucositis, degree of mucositis, chemotherapy regimen, type of blood cancer. For determining the association between the independent variable and the dependent will be used chi-square tests of association (Pearson) and Fisher's exact test, if necessary. Will calculate the risk ratio (RR) as a measure of relative risk, with the confidence interval at 95% (IC95%).Also be calculated NNT (number needed to treat to obtain benefit) and NNH (number needed to harm getting). Will be adopted a significance level of 5%. The project was approved by the Ethics and Research iMIP. All patients will be appropriately informed about the objectives of the project and will only be included if they voluntarily agree to participate by signing the consent form.
Keywords: laser, prevention and control; oral mucositis, bone marrow transplant.
详细描述
Inclusion Criteria: patients with blood cancers undergoing chemotherapy for
BMT; patients who agree to participate; patients older than 18 years.
Exclusion Criteria: patients with autoimmune diseases; patients who have sensitivity to the laser; patients who have already started treatment for mucositis prior to the research; HIV-positive patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with hematologic cancers undergoing chemotherapy for
- •patients who agree to participate;
- •patients older than 18 years.
排除标准
- •patients with autoimmune diseases;
- •patients who have sensitivity to the laser;
- •patients who have already started treatment for mucositis prior to research.
结局指标
主要结局
Incidence of Oral Mucositis
时间窗: From the first day after the transplantation to the eighth day after transplantation
From the first day after the transplantation to the eighth day after transplantation
次要结局
- Degree of mucositis(From the first day after the transplantation to the eighth day after transplantation)
研究者
Flavia orange
MD, PhD
Instituto Materno Infantil Prof. Fernando Figueira