Efficacy of photobiomodulation for the prevention and treatment of chemotherapy-induced oral mucositis in pediatric patients with hematologic cancers - a randomized clinical trial

Q: What condition and patient group does the trial focus on?

The trial addresses chemotherapy-induced oral mucositis in pediatric patients with hematologic cancers, with particular emphasis on MTX-induced oral mucositis.

Q: How were patients allocated in the prevention and treatment arms?

In the prevention arm, patients initially received no laser and were then reassigned to a PBM group in the next cycle for intra-patient comparison. In the treatment arm, patients diagnosed with oral mucositis were randomized to sham laser (control) or PDT (treatment).

Q: What outcomes showed effectiveness of PBM and PDT?

PBM significantly reduced oral mucositis incidence in the prevention arm. In the treatment arm, PDT using indocyanine green and low-level laser significantly reduced scores on WHO, NCI, and WCCNR scales at 3 and 5 days, with additional improvement in NCI from day 3 to day 5.

Sep 23, 2026

Uploaded by Jake

Oral mucositis is a debilitating complication affecting most children receiving chemotherapy. This dual-arm randomized clinical trial evaluated photobiomodulation (PBM) for prevention and photodynamic therapy (PDT) to treat methotrexate (MTX)-induced oral mucositis in pediatric patients with hematologic cancers. In the prevention arm, PBM significantly reduced incidence versus control, and in the treatment arm PDT significantly improved oral mucositis severity scores across multiple scales.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages14

Reading Time35 min

AccessFree to download

Abstract

Background

Methods

Results

Conclusion

Introduction

Lavaee etal. BMC Cancer (2025) 25:825 [https://doi.org/10.1186/s12885-025-14213-w](https://doi.org/10.1186/s12885-025-14213-w) BMC Cancer RESEARCH Open Access Efficacy of photobiomodulation for the prevention and treatment of chemotherapy-induced oral mucositisin pediatric patients with hematologic cancers: a randomized clinical trial Fatemeh Lavaee 1, Fahimeh Rezazadeh 1, Ali Amanati2,3*, Asma Sookhakian4*, Mohammad Amin Amiri5†, Navid Dehghani6† and Kiarash Fereidouni6† Abstract Background 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. Methods 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. Results 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) . Conclusion 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. †Mohammad Amin Amiri, Navid Dehghani and Kiarash Fereidouni contributed equally to this work. *Correspondence: Ali Amanati [ali_amanati_1356@yahoo.com](ali_amanati_1356@yahoo.com); dr. amanati [14@gmail.com](14@gmail.com) Asma Sookhakian [asma.soukhakian@gmail.com](asma.soukhakian@gmail.com) Full list of author information is available at the end of the article © The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creativecommons.org/licenses/by-nc-nd/4.0/](http://creativecommons.org/licenses/by-nc-nd/4.0/.)[.](http://creativecommons.org/licenses/by-nc-nd/4.0/.) Lavaee etal. BMC Cancer (2025) 25:825 Page 2 of 14 Trial registration The study has been registered on [irct.behdasht.gov.ir on 4 December 2022](irct.behdasht.gov.ir on 4 December 2022) (Trial Registration Number: IRCT20120101008585N16) . Keywords Hematology, Indocyanine Green, Laser Therapy, Mucositis, Neopl

FAQs

What condition and patient group does the trial focus on?

The trial addresses chemotherapy-induced oral mucositis in pediatric patients with hematologic cancers, with particular emphasis on MTX-induced oral mucositis.

How were patients allocated in the prevention and treatment arms?

In the prevention arm, patients initially received no laser and were then reassigned to a PBM group in the next cycle for intra-patient comparison. In the treatment arm, patients diagnosed with oral mucositis were randomized to sham laser (control) or PDT (treatment).

What outcomes showed effectiveness of PBM and PDT?

PBM significantly reduced oral mucositis incidence in the prevention arm. In the treatment arm, PDT using indocyanine green and low-level laser significantly reduced scores on WHO, NCI, and WCCNR scales at 3 and 5 days, with additional improvement in NCI from day 3 to day 5.

Sep 23, 2026

Uploaded by Jake