Evaluation of The Effect of Low Level Laser Therapy in The Prevention of Chemotherapy Induced Oral Mucositis in Children With Hematological Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- To measure incidence of oral mucositis in Laser arm versus Placebo arm.
研究概览
简要总结
Introduction:
Among the most drastic complications of chemotherapy is oral mucositis(OM). It is a painful inflammatory, often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol. Many treatment modalities have been introduced for the prevention and treatment of oral mucositis , of which low level laser therapy(LLLT) is gaining popularity. The use of LLLT as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence. Also, the parameters used have not been optimized and no standard method has yet been established. Based on this point, this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 children's cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced OM.
Aim:
To assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with Hematological cancers.
Methods:
This study is a randomized, prospective, double-blinded trial that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. These patients will be randomized into two groups: group 1 will receive low level laser therapy and group 2 will receive mock treatment. Patient will be followed to asses the development of oral mucositis on prespecified time points.
详细描述
This study is a randomized, prospective, double-blinded trial ( patient & outcome assessor) that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. These patients will be randomized by the Clinical Epidemiology unit using a computer-based method into two groups.
Group I: will receive Low Level Laser Therapy by Diode laser (Sirrolaser Blue ™, USA) at 44 different points in the oral cavity for 5 consequent days from Day 1 to Day 5 of chemotherapy cycle along with the standard preventive protocol in the hospital.
Group II: will receive a mock treatment which is the exact repetition of the treatment modality but without any laser emission beside the standard preventive protocol applied in the hospital.
All patients will be assessed for oral mucositis grade using NCI-CTCAE scale V4 and WHO score on days 1,5,12,19 and 30 .
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, Outcomes Assessor)
盲法说明
The outcome evaluator will be a single personnel from the oncology team following up with the case
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients diagnosed with Acute Myeloid Leukemia.
- •Children with a minimum age of 3 years and a maximum 18 years.
- •Children with sufficient cooperation to accept the treatment and evaluation periods
排除标准
- •Patients with limited mouth openings less than 1 cm, due to difficulty of laser radiation.
- •Patients with dysplastic oral lesions.
结局指标
主要结局
To measure incidence of oral mucositis in Laser arm versus Placebo arm.
时间窗: Oral mucositis will be evaluated on Days 1, 5, 12, 19 and 30.
Evaluate effectiveness of low level laser therapy for the Prevention of chemo-therapy induced oral mucositis.
To measure grade of oral mucositis in patients receiving laser arm placebo arm.
时间窗: Oral mucositis will be evaluated on Days 1, 5, 12, 19 and 30.
Oral mucositis will be graded in accordance with the classification criteria of the World Health Organization (WHO, and the National Cancer Institute scale (NCI - Common Terminology Criteria for Adverse Events, version 4.0) will also be used to compare the results.
次要结局
未报告次要终点