Double-blind, Randomized, Multi-center, Non-inferiority Clinical Trial Comparing Two Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 406
- 试验地点
- 17
- 主要终点
- Session evaluation
研究概览
简要总结
Chemotherapy-induced oropharyngeal mucositis (OM) negatively impacts the quality of life of adult and pediatric patients by causing pain, dysphagia, dysgeusia and dysphonia.
Photobiomodulation (PBM) by low level laser therapy (LLLT), light therapy of low level of red and infrared wavelengths (630-1000 nm) has been recommended since 2014 in patients treated with high-dose chemotherapy for bone marrow transplantation. Available pediatric studies highlighted positive/promising results of PBM with excellent safety and no adverse effects. Nevertheless, a wide variety of application parameters is described in the literature, with no consensus guidelines.
Considering the lack of standardized protocol of photobiomodulation in the pediatric population as well as the burden and cost of a daily application, investigators have decided to conduct, for the first time in children of 3 years of age or older, a multicenter, randomized, double-blind, non-inferiority clinical trial to compare two PBM protocols with same PBM parameters, combining red and infrared wavelengths, but with different frequencies of laser application (daily versus every other day), in the treatment of chemotherapy-induced OM of WHO grade 2 or higher.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female children aged ≥ 3 years and < 18 years.
- •Hospitalization in an oncology or hematology department in the participating centres.
- •Patients with oropharyngeal mucositis of grade 2 or higher (WHO grading system) related to cancer chemotherapy, including conditioning for Hematopoietic Stem Cell Transplantation (HSCT).
- •Written informed consent of both patient's holders of parental authority, and patient's assent when applicable.
- •Patients affiliated to a French Social Security insurance or equivalent social protection.
- •Absence of any physical or psychological disability that may interfere with the LLLT application.
排除标准
- •Patients with a solid cancer lesion in the area of low-level laser application.
- •History of cervicofacial radiotherapy.
- •Application of low-level laser therapy for oral mucositis within 2 weeks prior to randomization.
- •Hyperthyroidism defined by TSH < 0.4 IU/mL at inclusion.
- •Patients susceptible to epilepsy seizure.
- •Patients with pacemaker.
- •Patients refusing to wear retinal goggles during low-level laser
- •Patients with a solid cancer lesion in the area of low-level laser application.
- •Patients protected by law (guardianship and safeguarding of justice).
- •Pregnant female patients as determined by positive serum pregnancy test at screening.
- •Lactating female patients who are actively breast feeding.
- •Participation in another clinical trial involving oral care.
结局指标
主要结局
Session evaluation
时间窗: Throught treatment period up to 1 month
Duration (in days) from the day of first PBM session up to the day of first measurement when patient has no longer WHO grade 2 or higher chemotherapy-induced OM related pain at 2 consecutive measurements before the next scheduled PBM session (either active laser application or matching placebo application)
次要结局
- OM occurrence(2 months)
- Feed evaluation(2 months)
- Pain change evaluation(From baseline to each day of PBM session)
- Analgesic consumption(2 months)
- thyroid-stimulating hormone (TSH) evolution(From baseline to 2 months)
- Production costs evaluation(2 months)
- Health insurance evaluation(2 months)
- OM duration evaluation(Throught treatment period up to 1 month)
- PBM evaluation(Through treatment period up to 1 month)
- Adverse events occurrence(2 months)