小児における化学療法誘発性口腔粘膜炎の鎮痛におけるフォトバイオモジュレーションプロトコル (CURALASE01)
子供の化学療法誘発性口腔粘膜炎の鎮痛における2つのフォトバイオモジュレーションプロトコルを比較する二重盲検無作為化多施設非劣性臨床試験
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
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Angers、フランス
- University hospital of Angers
-
Besançon、フランス
- University hospital of Besançon
-
Grenoble、フランス
- University hospital of Grenoble
-
Lille、フランス
- University hospital of Lille
-
Limoges、フランス
- University hospital of Limoges
-
Marseille、フランス
- Hôpital La Timone
-
Nancy、フランス
- University hospital of Nancy
-
Nice、フランス
- University Hospital of Nice
-
Paris、フランス
- Armand Trousseau Hospital
-
Poitiers、フランス
- University hospital of Poitiers
-
Reims、フランス
- University hospital of Reims
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Rouen、フランス
- University hospital of Rouen
-
Saint-Etienne、フランス
- University hospital of Saint-Etienne
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Strasbourg、フランス
- University hospital of Strasbourg
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Tours、フランス
- University Hospital of Tours
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-
Occitanie
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Toulouse、Occitanie、フランス、31000
- University hospital of Toulouse
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 |
|
アクティブコンパレータ：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Session evaluation
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Production costs evaluation
時間枠：2 months
|
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
|
|
Health insurance evaluation
時間枠：2 months
|
Costs of inpatient hospital stays from the French health insurance perspective. |
2 months
|
|
OM duration evaluation
時間枠：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
|
|
OM occurrence
時間枠：2 months
|
Occurrence of chemotherapy-induced OM of WHO grade 3 or 4 (deterioration of the clinical situation). |
2 months
|
|
Feed evaluation
時間枠：2 months
|
Occurrence of enteral feeding. |
2 months
|
|
Analgesic consumption
時間枠：2 months
|
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
時間枠：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
|
|
Pain change evaluation
時間枠：From baseline to each day of PBM session
|
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
|
|
Adverse events occurrence
時間枠：2 months
|
Occurrence of adverse events reported according to descriptions and grading scale found in NCI CTCAE version 5.0. |
2 months
|
|
thyroid-stimulating hormone (TSH) evolution
時間枠：From baseline to 2 months
|
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
|
協力者と研究者
捜査官
- 主任研究者：Marlène PASQUET、University Hospital, Toulouse
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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