Scholarlink

<p>This study aims to compare the clinical efficacy of transcutaneous photobiomodulation (PBMT) with an 808&#xa0;nm infrared laser versus intraoral PBMT with a 660&#xa0;nm red laser in the prevention of oral mucositis (OM). The study is designed to assess whether the transcutaneous approach is non-inferior to the intraoral standard, thereby contributing to the optimization and standardization of PBMT protocols in head and neck cancer (HNC) supportive care. Methods: A randomized pilot study is being conducted with 54 patients (<i>n</i> = 27 per group) undergoing radiotherapy (60–70&#xa0;Gy) for HNC. Participants will be randomly assigned to receive either intraoral PBMT (660&#xa0;nm, 100 mW, 1&#xa0;J/point, fluence = 10.20&#xa0;J/ cm², 10&#xa0;s, 44 points) or transcutaneous PBMT (808&#xa0;nm, 100 mW, 1&#xa0;J/point, fluence = 34.5&#xa0;J/ cm² (central) and 4.3&#xa0;J/ cm² (lateral), 10&#xa0;s, 32 points). Interventions occur three times weekly throughout treatment. The primary outcome is OM severity, graded by WHO scale. Secondary outcomes include OM severity (NCI-CTCAE), pain intensity (Numeric Rating Scale, NRS), ulcerated area extension, registered through digital images, treatment interruptions and unscheduled healthcare utilization. Expected outcomes: the primary hypothesis posits that transcutaneous infrared PBMT is as effective as intraoral red PBMT in mitigating OM severity. Additionally, the transcutaneous approach is expected to offer logistical advantages, including a reduction in application time (80&#xa0;s vs. 440&#xa0;s) and improved tolerability in patients with radiation-induced trismus or severe oral pain. Conclusion: This protocol is expected to provide robust evidence to support the most feasible and effective PBMT modality for OM prevention. By optimizing treatment delivery, the study may enhance adherence, preserve nutritional status, and improve the quality of life for patients undergoing oncological therapy.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Comparative efficacy of two photobiomodulation protocols transcutaneous versus intraoral in the prevention of oral mucositis in head and neck cancer: a randomized study protocol

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月29日

查看全文
  • Waleska Tychanowicz Kolodziejwski,
  • Giovanna Leal Klein Renz,
  • Isabela Busnello de Souza,
  • Maria Luisa Franceschi Coimbra,
  • Luciana Almeida Lopes,
  • Laurindo Moacir Sassi,
  • Melissa Rodrigues de Araujo

摘要

This study aims to compare the clinical efficacy of transcutaneous photobiomodulation (PBMT) with an 808 nm infrared laser versus intraoral PBMT with a 660 nm red laser in the prevention of oral mucositis (OM). The study is designed to assess whether the transcutaneous approach is non-inferior to the intraoral standard, thereby contributing to the optimization and standardization of PBMT protocols in head and neck cancer (HNC) supportive care. Methods: A randomized pilot study is being conducted with 54 patients (n = 27 per group) undergoing radiotherapy (60–70 Gy) for HNC. Participants will be randomly assigned to receive either intraoral PBMT (660 nm, 100 mW, 1 J/point, fluence = 10.20 J/ cm², 10 s, 44 points) or transcutaneous PBMT (808 nm, 100 mW, 1 J/point, fluence = 34.5 J/ cm² (central) and 4.3 J/ cm² (lateral), 10 s, 32 points). Interventions occur three times weekly throughout treatment. The primary outcome is OM severity, graded by WHO scale. Secondary outcomes include OM severity (NCI-CTCAE), pain intensity (Numeric Rating Scale, NRS), ulcerated area extension, registered through digital images, treatment interruptions and unscheduled healthcare utilization. Expected outcomes: the primary hypothesis posits that transcutaneous infrared PBMT is as effective as intraoral red PBMT in mitigating OM severity. Additionally, the transcutaneous approach is expected to offer logistical advantages, including a reduction in application time (80 s vs. 440 s) and improved tolerability in patients with radiation-induced trismus or severe oral pain. Conclusion: This protocol is expected to provide robust evidence to support the most feasible and effective PBMT modality for OM prevention. By optimizing treatment delivery, the study may enhance adherence, preserve nutritional status, and improve the quality of life for patients undergoing oncological therapy.