儿童化疗引起的口腔粘膜炎镇痛中的光生物调节方案 (CURALASE01)
双盲、随机、多中心、非劣效性临床试验比较两种光生物调节方案在儿童化疗引起的口腔粘膜炎镇痛中的作用
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Angers、法国
- University hospital of Angers
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Besançon、法国
- University hospital of Besançon
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Grenoble、法国
- University hospital of Grenoble
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Lille、法国
- University hospital of Lille
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Limoges、法国
- University hospital of Limoges
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Marseille、法国
- Hôpital La Timone
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Nancy、法国
- University hospital of Nancy
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Nice、法国
- University Hospital of Nice
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Paris、法国
- Armand Trousseau Hospital
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Poitiers、法国
- University hospital of Poitiers
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Reims、法国
- University hospital of Reims
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Rouen、法国
- University hospital of Rouen
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Saint-Etienne、法国
- University hospital of Saint-Etienne
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Strasbourg、法国
- University hospital of Strasbourg
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Tours、法国
- University Hospital of Tours
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Occitanie
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Toulouse、Occitanie、法国、31000
- University hospital of Toulouse
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 1. 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：LLLT applied every other day
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day |
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day |
|
有源比较器：LLLT applied daily
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every day |
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied daily |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Session evaluation
大体时间：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) |
Throught treatment period up to 1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Production costs evaluation
大体时间：2 months
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Production costs from the hospital perspective and efficacy (i.e. number of days after which a child has no longer mucositis related pain as described in the primary endpoint section) to build Incremental Cost-Effectiveness Ratio (ICER) comparing every other day LLLT application versus with daily LLLT application. |
2 months
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Health insurance evaluation
大体时间：2 months
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Costs of inpatient hospital stays from the French health insurance perspective. |
2 months
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|
OM duration evaluation
大体时间：Throught treatment period up to 1 month
|
Duration (in days) of chemotherapy-induced OM of WHO grade 2 or higher between 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 at 2 consecutive measurements before the next scheduled PBM session (either every other day application or daily application). |
Throught treatment period up to 1 month
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|
OM occurrence
大体时间：2 months
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Occurrence of chemotherapy-induced OM of WHO grade 3 or 4 (deterioration of the clinical situation). |
2 months
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Feed evaluation
大体时间：2 months
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Occurrence of enteral feeding. |
2 months
|
|
Analgesic consumption
大体时间：2 months
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Duration (in days) of consumption of step 2 and step 3 analgesics during chemotherapy-induced OM of WHO grade 2 or higher. |
2 months
|
|
PBM evaluation
大体时间：Through 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) as evaluated, regardless of patient's age, with the ChIMES scale and use of step 3 analgesics. |
Through treatment period up to 1 month
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Pain change evaluation
大体时间：From baseline to each day of PBM session
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Change over time in WHO grade 2 or higher chemotherapy-induced OM related pain, as assessed by pain scales (HEDEN (Hétero Evaluation Douleur Enfant) mucositis scale (5 items ranging from 0 to 2) or VAS (ranging from 0 to 10)depending on patient's age category, and Children's International Mucositis Evaluation Scale (4 items ranging from 0 to 5) whatever patient's age category) |
From baseline to each day of PBM session
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|
Adverse events occurrence
大体时间：2 months
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Occurrence of adverse events reported according to descriptions and grading scale found in NCI CTCAE version 5.0. |
2 months
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thyroid-stimulating hormone (TSH) evolution
大体时间：From baseline to 2 months
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TSH shift from baseline value classified according to the following three categories: "< 0.4 IU/mL", "[0.4 - 10] IU/mL", "> 10 IU/mL", to value at D14-31 after end of WHO grade 2 or higher chemotherapy-induced OM classified according to the same three categories. |
From baseline to 2 months
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合作者和调查者
调查人员
- 首席研究员：Marlène PASQUET、University Hospital, Toulouse
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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