LAMPO: Multicenter Randomized Double-blind Controlled Trial to Evaluate the Efficacy of Laser Therapy for Treatment of Oral Mucositis Induced by Chemotherapy in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 8
- 主要终点
- Reduction of the grade of oral mucositis
研究概览
简要总结
Children with cancer undergoing intensive chemotherapy (CT) regimens experience many side effects among which oral mucositis (OM) is one of the most debilitating. Modifications of CT's schedule and prolonged hospitalization may be necessary in presence of OM, causing poor general conditions and debilitation. Moreover, the use of narcotic analgesics and total parenteral nutrition may be required, triggering not only a physical deficit but also an economic burden. Despite the frequency and impact of OM among children with cancer, there is no consensus on standard therapy for this condition. Previous studies demonstrated that high power laser therapy can help the maintenance of nutritional status in patients with OM and can remarkably reduce costs/resources needed. Laser therapy has evidence of efficacy in reducing symptoms and in preventing the onset of OM in adult cancer patients but only one randomized controlled trial, with a limited number of children enrolled, supports its use in children for treatment of OM induced by chemotherapy.
This multicenter double-blind randomized controlled trial evaluates the efficacy of laser for treatment of oral mucositis secondary to chemotherapy in children aged 3-17 years.
The study involves 8 italian hospitals.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Children aged 3-18 years
- •Oral mucositis of grade 3 or 4 at enrollment (CTC - WHO scale)
- •Antiblastic chemotherapy in the in the previous three weeks
- •Willingness to undergo treatment for 4 consecutive days and to return for evaluation 7 and 11 days after enrollment.
排除标准
- •Previous treatment with laser therapy for stomatitis
- •Presence of dysplastic oral lesions
- •Reduction of mouth opening (<1 cm)
- •Localized head and/or neck radiation treatment in the previous 4 weeks
- •Use of keratinocyte growth factor (KGF)
- •Previous enrollment in the study
结局指标
主要结局
Reduction of the grade of oral mucositis
时间窗: 7 days after enrollment
Reduction of stomatitis' grade (from grade 3 or 4 to a lower grade). The grade of stomatitis is defined using the World Health Organization (WHO) evaluation scale
次要结局
- Reduction of pain, age 4-7 years(11 days after enrollment)
- Reduction of need for analgesics(at day 7)
- Reduction of the grade of oral mucositis(11 days after enrollment)
- Reduction of pain, age 8-18 years(11 days after enrollment)
- Adverse events(at day 11)
研究者
Ronfani Luca
MD, PhD
IRCCS Burlo Garofolo