Photobiomodulation Therapy in the Prevention of Chemotherapy Induced Oral Mucositis in Children with Acute Myeloid Leukemia: A Randomized, Double-blind, Clinical trial

IF 2.4 3区医学 Q2 HEMATOLOGY

Pediatric Blood & Cancer Pub Date : 2024-11-06 DOI:10.1002/pbc.31400

Reem E. Elkady, Reham Khedr, Mohammed Hassan, Samy El Bayoumy, Sonia Mahmoud, Ebtisam Hanafy, Salam ElAraby, Alaa El Haddad

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Abstract

Background

Many preventive modalities have been advocated to reduce the incidence and severity of chemotherapy-induced Oral Mucositis (OM). Photobiomodulation, also known as Low-Level laser. Therapy, has shown promising results. This clinical trial was performed to evaluate the effectiveness of Photobiomodulation (PBM) for the prevention of chemotherapy-induced oral mucositis (OM) in children with Acute Myeloid Leukemia (AML).

Patients and methods

A double-blinded randomized clinical trial was performed, including forty-two children diagnosed with Acute Myeloid Leukemia (AML) admitted to receiving chemotherapy (CT) at Children's Cancer Hospital 57357, Cairo, Egypt. Patients were randomly assigned to either the control or test group. Both groups followed the standard preventive protocol for oral mucositis. In the control group I sham therapy, while in the Laser group I had Photobiomodulation sessions for five consecutive days once a day performed by Diode laser (Sirrolaser Blue ™, USA) 660nm, 15watt, 10 s. Laser sessions began on day 1 of chemotherapy and were repeated on days 2,3, 4, and 5. The response to both groups was evaluated according to the development of oral mucositis; graded using 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). Incidence of oral mucositis was evaluated from baseline to 5, 12, 19, and 30 days after treatment.

Results

A clinical significant difference between the laser and control group was observed. The laser group showed a higher prevalence of no oral mucositis with decreased incidence of OM, while on day 12, the control group showed a higher prevalence of grades I and II (P-value <0.001, effect size = 0.796). However, the laser group showed higher prevalence of mucosa free of OM; on day 19, the control group showed higher rates of grades II and III, (P-value <0.001, effect size = 0.670). while on day 30 there was higher rates of grades I and II (P-value <0.001, effect size = 0.576) with higher rates of healthy oral mucosa in the laser group.

Conclusion

Photobiomodulation effectively reduces the incidence and severity of chemotherapy-induced oral mucositis in pediatric patients diagnosed with AML.

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光生物调节疗法用于预防急性髓性白血病患儿化疗引起的口腔黏膜炎：随机、双盲临床试验。

背景：为了降低化疗引起的口腔黏膜炎（OM）的发病率和严重程度，人们提倡了许多预防方法。光生物调节，又称低水平激光治疗，已显示出良好的效果。光生物调节也被称为低强度激光治疗，已显示出良好的效果。本临床试验旨在评估光生物调制（PBM）在预防急性髓性白血病（AML）患儿化疗诱发的口腔黏膜炎（OM）方面的效果：埃及开罗 57357 号儿童癌症医院开展了一项双盲随机临床试验，42 名确诊为急性髓性白血病（AML）的儿童接受了化疗（CT）。患者被随机分配到对照组或试验组。两组均采用标准的口腔黏膜炎预防方案。在对照组中，我接受了假治疗，而在激光组中，我接受了连续五天的光生物调节治疗，每天一次，使用二极管激光器（Sirrolaser Blue ™，美国），波长 660nm，功率 15 瓦，时间 10 秒。根据口腔粘膜炎的发生情况对两组患者的反应进行评估；采用世界卫生组织（WHO）的分类标准和美国国立癌症研究所的评分标准（NCI - 不良事件通用术语标准，4.0 版）进行分级。从基线到治疗后5天、12天、19天和30天，对口腔黏膜炎的发生率进行了评估：结果：激光组和对照组之间存在明显的临床差异。激光组无口腔黏膜炎的发生率较高，口腔黏膜炎的发生率较低，而对照组在治疗后第 12 天出现 I 级和 II 级口腔黏膜炎的发生率较高（P 值结论：光生物调制能有效降低口腔黏膜炎的发生率：光生物调节可有效降低急性髓细胞白血病儿科患者化疗引起的口腔黏膜炎的发生率和严重程度。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pediatric Blood & Cancer 医学-小儿科

CiteScore

4.90

自引率

9.40%

发文量

546

审稿时长

1.5 months

期刊介绍： Pediatric Blood & Cancer publishes the highest quality manuscripts describing basic and clinical investigations of blood disorders and malignant diseases of childhood including diagnosis, treatment, epidemiology, etiology, biology, and molecular and clinical genetics of these diseases as they affect children, adolescents, and young adults. Pediatric Blood & Cancer will also include studies on such treatment options as hematopoietic stem cell transplantation, immunology, and gene therapy.