Extraoral photobiomodulation for prevention of oral and oropharyngeal mucositis in head and neck cancer patients: interim analysis of a randomized, double-blind, clinical trial
Kauark-Fontes E, Migliorati CA, Epstein JB, Treister NS, Alves CGB, Faria KM, Palmier NR, Rodrigues-Oliveira L, de Pauli Paglioni M, Gueiros LAM, da Conceição Vasconcelos KGM, de Castro G, Leme AFP, Lopes MA, Prado-Ribeiro AC, Brandão TB, Santos-Silva AR
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 31 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Gobierno
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Gobierno
- fundação de amparo à pesquisa do estado de são paulo
- Subvenciones
- Fundação de Amparo à Pesquisa do Estado de São Paulo (2018/23479‐3); Conselho Nacional de Desenvolvimento Científico e Tecnológico (2018/02233-6); Fundação de Amparo à Pesquisa do Estado de São Paulo (18/02233-6)
Según 3 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2021-10-27 · Support Care Cancer · vol. 30 · número 3 · págs. 2225–2236
- Editorial
- Springer Science+Business Media
- Citado
- 48 citas · más que el 96% de estudios similares · 4.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 47 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Oral health in cancer treatment · Oral Health Pathology and Treatment · Head and Neck Cancer Studies
- Palabras clave
- oral mucositis, oropharyngeal mucositis, head and neck cancer, oral squamous cell carcinoma, oropharyngeal squamous cell carcinoma, radiotherapy complications, mucositis prevention, pain, quality of life, analgesic use, anti-inflammatory agents
- MeSH
- humans, head and neck neoplasms, stomatitis, double-blind method, quality of life, mucositis, low-level light therapy
17 autores
- ELISA KAUARK FONTES🇧🇷Universidade Estadual de Campinas (UNICAMP)
- Cesar Augusto Migliorati🇺🇸University of Florida
- Joel Brian Epstein🇺🇸Cedars-Sinai Medical Center; City Of Hope National Medical Center; City of Hope
- Nathaniel Simon Treister🇺🇸Brigham and Women's Hospital; Harvard University
- Carolina Guimarães Bonfim Alves🇧🇷Universidade Estadual de Campinas (UNICAMP); Instituto do Câncer do Estado de São Paulo
- Karina Morais Faria🇧🇷Instituto do Câncer do Estado de São Paulo
- Natália Rangel Palmier🇧🇷Universidade Estadual de Campinas (UNICAMP); Instituto do Câncer do Estado de São Paulo
- Letícia Rodrigues‐Oliveira🇧🇷Universidade Estadual de Campinas (UNICAMP)
- Mariana de Pauli Paglioni🇧🇷Universidade Estadual de Campinas (UNICAMP)
- Luiz Alcino Gueiros🇧🇷Universidade Federal de Pernambuco
- Karina Gondim Moutinho da Conceição Vasconcelos🇧🇷Universidade de São Paulo; Instituto do Câncer do Estado de São Paulo
- Gilberto de Castro🇧🇷Instituto do Câncer do Estado de São Paulo
- Adriana Franco Paes Leme🇧🇷Brazilian Center for Research in Energy and Materials; Brazilian Biosciences National Laboratory
- Márcio Ajudarte Lopes🇧🇷Universidade Estadual de Campinas (UNICAMP)
- Ana Carolina Prado Ribeiro🇧🇷Instituto do Câncer do Estado de São Paulo
- Thaís Bianca Brandão🇧🇷Instituto do Câncer do Estado de São Paulo
- Alan Roger Santos‐Silva🇧🇷 · autor de correspondenciaUniversidade Estadual de Campinas (UNICAMP)
Resumen
El texto original del estudio, en el idioma en que se publicó.
Purpose
To assess the safety and efficacy of prophylactic extraoral photobiomodulation (PBM) for the prevention of oral and oropharyngeal mucositis (OM) on clinical outcomes and survival in patients with oral cavity and oropharyngeal squamous cell carcinoma (OOPSCC).
Methods
OOPSCC patients who received radiotherapy (RT) were prospectively randomized to two groups: prophylactic extraoral PBM and placebo. OM grade (NCI), pain (VAS), analgesia, and anti-inflammatory prescriptions were assessed weekly. Quality of life questionnaires (QoL) were performed at the first and last day of RT. Following RT, participants were evaluated quarterly for oncological outcomes follow-up.
Results
Fifty-five patients met the inclusion criteria. The first occurrence of OM was observed at week 1, for the placebo group (p = 0.014). Later, OM onset and severity was observed for the PBM group, with first occurrence at week 2 (p = 0.009). No difference in severe OM incidence was observed (p > 0.05). Lower mean pain score was noted at week 7 for the PBM group (2.1) compared to placebo group (4.5) (p = 0.009). Less analgesics (week 3; p = 0.009/week 7; p = 0.02) and anti-inflammatory prescription (week 5; p = 0.0346) were observed for the PBM group. Better QoL scores were observed for the PBM group at last day of RT (p = 0.0034). No difference in overall survival among groups was observed in 1 year of follow-up (p = 0.889).
Conclusion
Prophylactic extraoral PBM can delay OM onset, reduce pain, and reduce analgesic and anti-inflammatory prescription requirements. Extraoral PBM was associated with better QoL. There was no evidence of PBM impact on oncological outcomes.
Trial registration
TRN:RBR-4w4swx (date of registration: 01/20/2020).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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