Lavaee Fatemeh, Rezazadeh Fahimeh, Amanati Ali, Sookhakian Asma, Amiri Mohammad Amin, Dehghani Navid, Fereidouni Kiarash
Oral and Dental Disease Research Center, Department of Oral and Maxillofacial Medicine, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.
Clinical Research Development Center, Amir Oncology Teaching Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.
BMC Cancer. 2025 May 2;25(1):825. doi: 10.1186/s12885-025-14213-w.
Oral mucositis (OM) is a debilitating treatment-related complication that affects most children undergoing chemotherapy. This dual-arm clinical trial aimed to evaluate the efficacy of photobiomodulation (PBM) for prevention and photodynamic therapy (PDT) using indocyanine green (ICG) and low-level laser for treating methotrexate (MTX)-induced OM in pediatric patients with hematologic cancers.
In the prevention arm, patients were initially assigned to a control group (received no laser) and subsequently reassigned to a PBM group in their next cycle, allowing intra-patient comparison under similar chemotherapy protocols. In the treatment arm, patients diagnosed with OM were randomly assigned to either a control group (sham laser) or a PDT group.
In the prevention arm, PBM led to a significant reduction in the incidence of OM from 66.67% to 6.67% (p < 0.05). In the treatment arm, the PDT group showed a significant reduction in the scores of all scales (WHO, NCI, and WCCNR) at both 3 days and 5 days after starting the treatment compared to the control group (p < 0.05). Moreover, the reduction in the NCI score from the third to the fifth days after the starting treatment is higher in the PDT group compared to the control group (p < 0.05).
PBM appears to be a safe and effective approach for the prevention of MTX-induced OM in pediatric patients with hematologic cancers. Additionally, PDT using ICG and a low-level laser demonstrates promising results in treating OM lesions. Therefore, these findings highlight the efficacy of PBM for managing MTX-induced OM in this patient group.
The study has been registered on irct.behdasht.gov.ir on 4 December 2022 (Trial Registration Number: IRCT20120101008585N16).
口腔黏膜炎（OM）是一种使人虚弱的与治疗相关的并发症，影响大多数接受化疗的儿童。这项双臂临床试验旨在评估光生物调节（PBM）预防的疗效，以及使用吲哚菁绿（ICG）和低强度激光的光动力疗法（PDT）治疗血液系统癌症儿科患者中由甲氨蝶呤（MTX）引起的OM的疗效。
在预防组中，患者最初被分配到对照组（未接受激光治疗），随后在下一个周期重新分配到PBM组，以便在相似的化疗方案下进行患者内比较。在治疗组中，被诊断为OM的患者被随机分配到对照组（假激光治疗）或PDT组。
在预防组中，PBM使OM的发生率从66.67%显著降低至6.67%（p<0.05）。在治疗组中，与对照组相比，PDT组在开始治疗后第3天和第5天所有量表（WHO、NCI和WCCNR）的评分均显著降低（p<0.05）。此外，与对照组相比，PDT组在开始治疗后第3天至第5天NCI评分的降低幅度更大（p<0.05）。
PBM似乎是预防血液系统癌症儿科患者中MTX引起的OM的一种安全有效的方法。此外，使用ICG和低强度激光的PDT在治疗OM病变方面显示出有前景的结果。因此，这些发现突出了PBM在管理该患者群体中MTX引起的OM方面的疗效。
该研究于2022年12月4日在irct.behdasht.gov.ir上注册（试验注册号：IRCT20120101008585N16）。
