Financiado en parte por Funding for this study, including data collection, monitoring, statistical analysis and medical writing, was provided by MuReva Phototherapy Inc. (Brecksville, Ohio, USA).
Randomized, double-blind, sham-controlled trial of an intraoral photobiomodulation device for oral mucositis and associated complications due to radiotherapy for head and neck cancer
Hu K, Shah P, Nguyen MC, McCluskey C, Kane A, Ove R, Willey CD, Katz S, Marathe O, Valentin S, Frustino J, Villa A, Spencer S, Holtzapfel C, Treister N, Lalla RV
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 1 cita
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Cómo se estudió
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Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Funding for this study, including data collection, monitoring, statistical analysis and medical writing, was provided by MuReva Phototherapy Inc. (Brecksville, Ohio, USA).
Según 1 financiador declarado.
Publicación
- Publicado
- 2026-06-26 · Support Care Cancer · vol. 34 · número 7
- Editorial
- Springer Science+Business Media
- Citado
- 0 citas · más que el 50% de estudios similares · 0.0× el promedio de su campo
- Referencias
- 33 trabajos
- Acceso
- De pago
- Áreas de investigación
- Oral health in cancer treatment · Laser Applications in Dentistry and Medicine · Oral Health Pathology and Treatment
- Palabras clave
- low-level laser therapy, oral mucositis, head and neck cancer, intensity-modulated radiotherapy, concurrent chemoradiotherapy, feeding tube dependence, radiation toxicity prevention, sham-controlled treatment, device safety and tolerability, sore throat, patient-reported outcomes
- MeSH
- humans, head and neck neoplasms, stomatitis, radiation injuries, severity of illness index, incidence, double-blind method, adult, aged, middle aged, female, male, radiotherapy, intensity-modulated, low-level light therapy
16 autores
- Kenneth Shung Hu🇺🇸 · autor de correspondenciaNYU Langone Health; New York University
- Pratish Shah🇺🇸St. Elizabeth Healthcare
- M. Connie Nguyen🇺🇸Oklahoma Cancer Specialists and Research Institute
- Cornelia McCluskey🇺🇸Christ Hospital
- Anne Kane🇺🇸University of Mississippi Medical Center; University of Alabama at Birmingham
- Roger Ove🇺🇸MetroHealth; Case Western Reserve University
- Christopher D. Willey🇺🇸University of Alabama at Birmingham
- Sanford R. Katz🇺🇸Willis-Knighton Cancer Center
- Omkar Subhash Marathe🇺🇸Oncology Institute of Hope and Innovation
- Sasha Valentin🇺🇸The Ohio State University
- Jennifer L. Frustino🇺🇸Erie County Medical Center
- Alessandro Villa
- Sharon A. Spencer🇺🇸University of Alabama at Birmingham
- Catherine Holtzapfel🇺🇸St. Elizabeth Healthcare
- Nathaniel Simon Treister🇺🇸Brigham and Women's Hospital
- Rajesh V. Lalla🇺🇸UConn Health
Resumen
El texto original del estudio, en el idioma en que se publicó.
Purpose
This study evaluated the safety and effectiveness of an intraoral light-emitting diode (LED)-based photobiomodulation (PBM) device to reduce the incidence and severity of oral mucositis (OM) from intensity modulated radiation therapy (IMRT) for head and neck cancer (HNC).
Methods
This randomized, double-blind, sham-controlled trial enrolled patients with HNC undergoing high-dose IMRT over 6-8 weeks, with or without concurrent chemotherapy. Participants received daily 10-min PBM or sham treatments immediately before IMRT sessions. Assessments were conducted at baseline, daily and weekly during IMRT, and two weeks post-IMRT.
Results
Eighty-five participants (42 PBM; 43 sham) were enrolled across 12 US sites. No device-related adverse events were observed, and 99.5% of initiated sessions were completed. In the intent-to-treat population, severe OM (WHO Grade ≥ 3) incidence was significantly lower with PBM across six weeks of IMRT (36.8% vs 57.1%; p = 0.046) and at two weeks post-treatment (10.8% vs 36.4%; p = 0.042). In the per-protocol population, the PBM arm reported significantly greater taste preservation (p = 0.034), lower increases in mouth/throat soreness (p = 0.029) and throat pain (p = 0.028) and needed fewer feeding tube placements (p = 0.073) than the control arm.
Conclusion
Daily intraoral PBM therapy using an LED-based device was safe, well tolerated, and significantly reduced the incidence of severe OM and associated complications in HNC patients undergoing IMRT with or without concurrent chemotherapy. These findings align with guidelines recommending daily intraoral PBM therapy for preventing cancer therapy-related OM, a dose-limiting toxicity for which effective preventive interventions are needed.
Trial registration
Clinical Trials.gov Registration Number NCT03972527. Registered on June 3, 2019. Daily intraoral PBM therapy using an LED-based device was safe, well tolerated, and significantly reduced the incidence of severe OM and associated complications in HNC patients undergoing IMRT with or without concurrent chemotherapy. These findings align with guidelines recommending daily intraoral PBM therapy for preventing cancer therapy-related OM, a dose-limiting toxicity for which effective preventive interventions are needed.
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