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Oncological safety of the use of intraoral and extraoral photobiomodulation in patients with oral cavity and oropharyngeal squamous cell carcinoma

Grant number: 18/02233-6
Support type:Regular Research Grants
Duration: September 01, 2018 - August 31, 2020
Field of knowledge:Health Sciences - Dentistry
Principal researcher:Alan Roger dos Santos Silva
Grantee:Alan Roger dos Santos Silva
Home Institution: Faculdade de Odontologia de Piracicaba (FOP). Universidade Estadual de Campinas (UNICAMP). Piracicaba , SP, Brazil
Assoc. researchers:Adriana Franco Paes Leme ; Ana Carolina Prado Ribeiro e Silva ; Cesar Augusto Migliorati ; Gilberto de Castro Junior ; Natália Rangel Palmier ; Thaís Bianca Brandão

Abstract

Aims: To assess, at clinical and molecular levels, the impact of prophylactic low-level laser therapy (photobiomodulation) for oral and oropharyngeal mucositis (OM) in the survival rates of patients with oral cavity and oropharyngeal squamous cell carcinoma (OSCC). Patients and Methods: 120 patients diagnosed with OSCC that will initiate curative protocols of adjuvant radiotherapy (RT) or chemoradiotherapy (CRT) will be prospectively assessed. Patients will be randomly allocated into four groups; Intraoral prophylactic photobiomodulation (n=30) (InGaAlP; 660 nm, 40 mW, energy density of 10 J/cm2, 0.4J of energy/spot; 10 s/spot, 4mm2 spot size); Extraoral prophylactic photobiomodulation (n=30) (LED 69 diode, 34x660 nm (10 mW) and 35x850 nm (30 mW), 1390 mW, energy density 50 mW /cm2, 3.0J of energy/cm2, 60s/spot, spot size (? cm2 ); Placebo intraoral photobiomodulation sham laser (n=30) and Placebo extraoral photobiomodulation sham laser (n=30). OM degree and OM associated pain will be assessed daily during the RT (NCI, Version 4.0, 2010; WHO, 1975 e VAS). The impact of the photobiomodulation will be evaluated quarterly during 18 months following RT conclusion, regarding the following oncological outcomes: local recurrences, development of second primary tumors, mean time of disease free survival and overall survival. For the analysis of the impact of photobiomodulation in molecular biomarkers of carcinogenesis, whole saliva samples will be collected at 3 different time points (D-1; D30 and D+30RT) followed by proteomic analysis based on mass spectrometry (MS/MS). Expected results: To contribute to a better understanding, in oncological terms, of the safety of photobiomodulation protocols regarding RT induced OM. (AU)

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Scientific publications (14)
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
KAUARK-FONTES, ELISA; MIGLIORATI, CESAR AUGUSTO; EPSTEIN, JOEL B.; TREISTER, NATHANIEL SIMON; BONFIM ALVES, CAROLINA GUIMARAES; FARIA, KARINA MORAIS; PALMIER, NATALIA RANGEL; RODRIGUES-OLIVEIRA, LETICIA; PAGLIONI, MARIANA DE PAULI; MONTEIRO GUEIROS, LUIZ ALCINO; DA CONCEICAO VASCONCELOS, KARINA G. M.; DE CASTRO JR, GILBERTO; PAES LEME, ADRIANA FRANCO; LOPES, MARCIO AJUDARTE; PRADO-RIBEIRO, ANA CAROLINA; BRANDAO, THAIS BIANCA; SANTOS-SILVA, ALAN ROGER. Extraoral photobiomodulation for prevention of oral and oropharyngeal mucositis in head and neck cancer patients: interim analysis of a randomized, double-blind, clinical trial. SUPPORTIVE CARE IN CANCER, v. 30, n. 3 OCT 2021. Web of Science Citations: 0.
MARTINS, BEATRIZ NASCIMENTO FIGUEIREDO LEBRE; PALMIER, NATALIA RANGEL; PRADO-RIBEIRO, ANA CAROLINA; DE GOES, MARIO FERNANDO; LOPES, MARCIO AJUDARTE; BRANDA, THAIS BIANCA; RIVERA, CESAR; MIGLIORATI, CESAR AUGUSTO; EPSTEIN, JOEL B.; SANTOS-SILVA, ALAN ROGER. Awareness of the risk of radiation-related caries in patients with head and neck cancer: A survey of physicians, dentists, and patients. ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY ORAL RADIOLOGY, v. 132, n. 4, p. 398-408, OCT 2021. Web of Science Citations: 0.
SILVEIRA, FELIPE MARTINS; SCHMIDT, TUANY RAFAELI; NEUMANN, BRUNA; ROSSET, CLEVIA; ZANELLA, VIRGILIO GONZALES; MAAHS, GERSON SCHULZ; TREVIZANI MARTINS, MARCO ANTONIO; ARANY, PRAVEEN; WAGNER, VIVIAN PETERSEN; LOPES, MARCIO AJUDARTE; SANTOS-SILVA, ALAN ROGER; MARTINS, MANOELA DOMINGUES. Impact of photobiomodulation in a patient-derived xenograft model of oral squamous cell carcinoma. ORAL DISEASES, JUL 2021. Web of Science Citations: 0.
PALMIER, NATALIA RANGEL; PAES LEME, ADRIANA FRANCO; DE ROSSI, TATIANE; TELLES, GUILHERME PIMENTEL; MORAIS-FARIA, KARINA; KOWALSKI, LUIZ PAULO; MARTA, GUSTAVO NADER; BRANDAO, THAIS BIANCA; ARANY, PRAVEEN R.; MIGLIORATI, CESAR AUGUSTO; SANTOS-SILVA, ALAN ROGER; PRADO-RIBEIRO, ANA CAROLINA. Salivary alpha-1-antitrypsin and macrophage migration inhibitory factor may be potential prognostic biomarkers for oncologic treatment-induced severe oral mucositis. SUPPORTIVE CARE IN CANCER, v. 29, n. 6, p. 2939-2946, JUN 2021. Web of Science Citations: 0.
KAUARK-FONTES, ELISA; RODRIGUES-OLIVEIRA, LETICIA; EPSTEIN, JOEL B.; FARIA, KARINA MORAIS; ARAUJO, ANNA LUIZA DAMACENO; GUEIROS, LUIZ ALCINO MONTEIRO; MIGLIORATI, CESAR AUGUSTO; SALLOUM, RAMZI G.; BURTON, PATRICIA; CARROLL, JAMES; LOPES, MARCIO AJUDARTE; ALVES, CAROLINA GUIMARAES BONFIM; PALMIER, NATALIA RANGEL; PRADO-RIBEIRO, ANA CAROLINA; BRANDAO, THAIS BIANCA; SANTOS-SILVA, ALAN ROGER. Cost-effectiveness of photobiomodulation therapy for the prevention and management of cancer treatment toxicities: a systematic review. SUPPORTIVE CARE IN CANCER, v. 29, n. 6 JAN 2021. Web of Science Citations: 0.
OLIVEIRA CORREA ROZA, ANA LUIZA; KOWALSKI, LUIZ PAULO; WILLIAM JR, WILLIAM NASSIB; DE CASTRO JR, GILBERTO; FREITAS CHAVES, ALINE LAUDA; DAMACENO ARAUJO, ANNA LUIZA; PRADO RIBEIRO, ANA CAROLINA; BRANDAO, THAIS BIANCA; LOPES, MARCIO AJUDARTE; VARGAS, PABLO AGUSTIN; SANTOS-SILVA, ALAN ROGER; GR, LATIN AMER COOPERATIVE ONCOLOGY; CANC, BRAZILIAN GRP HEAD NECK. Oral leukoplakia and erythroplakia in young patients: a systematic review. ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY ORAL RADIOLOGY, v. 131, n. 1, p. 73-84, JAN 2021. Web of Science Citations: 0.
MORAIS-FARIA, KARINA; PALMIER, NATALIA RANGEL; CORREIA, JAQUELINE DE LIMA; DE CASTRO JUNIOR, GILBERTO; DIAS, REINALDO BRITO; PINTO, HENRIQUE DA GRACA; LOPES, MARCIO AJUDARTE; PRADO RIBEIRO, ANA CAROLINA; BRANDAO, THAIS BIANCA; SANTOS-SILVA, ALAN ROGER. Young head and neck cancer patients are at increased risk of developing oral mucositis and trismus. SUPPORTIVE CARE IN CANCER, v. 28, n. 9, p. 4345-4352, SEP 2020. Web of Science Citations: 0.
GOUVEA VASCONCELLOS, ADRIELE FERREIRA; PALMIER, NATALIA RANGEL; RIBEIRO, ANA CAROLINA PRADO; NORMANDO, ANA GABRIELA COSTA; MORAIS-FARIA, KARINA; GOMES-SILVA, WAGNER; VECHIATO FILHO, ALJOMAR JOSE; DE GOES, MARIO FERNANDO; PAES LEME, ADRIANA FRANCO; BRANDAO, THAIS BIANCA; LOPES, MARCIO AJUDARTE; MARSH, PHILIP D.; SANTOS-SILVA, ALAN ROGER. Impact of Clustering Oral Symptoms in the Pathogenesis of Radiation Caries: A Systematic Review. Caries Research, v. 54, n. 2, p. 113-126, AUG 2020. Web of Science Citations: 1.
FARIA, KARINA MORAIS; GOMES-SILVA, WAGNER; KAUARK-FONTES, ELISA; BONFIM-ALVES, CAROLINA GUIMARAES; KOWALSKI, LUIZ PAULO; PRADO-RIBEIRO, ANA CAROLINA; VECHIATO-FILHO, ALJOMAR JOSE; LOPES, MARCIO AJUDARTE; MARTA, GUSTAVO NADER; DE CASTRO JR, GILBERTO; PAES LEME, ADRIANA FRANCO; MIGLIORATI, CESAR AUGUSTO; SANTOS-SILVA, ALAN ROGER; BRANDAO, THAIS BIANCA. Impact of pandemic COVID-19 outbreak on oral mucositis preventive and treatment protocols: new perspectives for extraoral photobiomodulation therapy. SUPPORTIVE CARE IN CANCER, v. 28, n. 10 JUL 2020. Web of Science Citations: 0.
PAGLIONI, MARIANA DE PAULI; FARIA, KARINA MORAIS; PALMIER, NATALIA RANGEL; PRADO-RIBEIRO, ANA CAROLINA; BRITO E DIAS, REINALDO; DA GRACA PINTO, HENRIQUE; TREISTER, NATHANIEL SIMON; EPSTEIN, JOEL B.; MIGLIORATI, CESAR AUGUSTO; SANTOS-SILVA, ALAN ROGER; BRANDAO, THAIS BIANCA. Patterns of oral mucositis in advanced oral squamous cell carcinoma patients managed with prophylactic photobiomodulation therapy-insights for future protocol development. Lasers in Medical Science, v. 36, n. 2 JUL 2020. Web of Science Citations: 0.
PALMIER, NATALIA RANGEL; MIGLIORATI, CESAR AUGUSTO; PRADO-RIBEIRO, ANA CAROLINA; QUERIDO DE OLIVEIRA, MARIA CECILIA; VECHIATO FILHO, ALJOMAR JOSE; DE GOES, MARIO FERNANDO; BRANDAO, THAIS BIANCA; LOPES, MARCIO AJUDARTE; SANTOS-SILVA, ALAN ROGER. Radiation-related caries: current diagnostic, prognostic, and management paradigms. ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY ORAL RADIOLOGY, v. 130, n. 1, p. 52-62, JUL 2020. Web of Science Citations: 0.
DE PAULI PAGLIONI, MARIANA; ALVES, CAROLINA GUIMARAES BONFIM; FONTES, ELISA KAUARK; LOPES, MARCIO AJUDARTE; RIBEIRO, ANA CAROLINA PRADO; BRANDAO, THAIS BIANCA; MIGLIORATI, CESAR AUGUSTO; SANTOS-SILVA, ALAN ROGER. Is photobiomodulation therapy effective in reducing pain caused by toxicities related to head and neck cancer treatment? A systematic review. SUPPORTIVE CARE IN CANCER, v. 27, n. 11, p. 4043-4054, NOV 2019. Web of Science Citations: 0.
SILVEIRA, FELIPE MARTINS; PAGLIONI, MARIANA DE PAULI; MARQUES, MARCIA MARTINS; SANTOS-SILVA, ALAN ROGER; MIGLIORATI, CESAR AUGUSTO; ARANY, PRAVEEN; MARTINS, MANOELA DOMINGUES. Examining tumor modulating effects of photobiomodulation therapy on head and neck squamous cell carcinomas. PHOTOCHEMICAL & PHOTOBIOLOGICAL SCIENCES, v. 18, n. 7, p. 1621-1637, JUL 1 2019. Web of Science Citations: 0.
PAGLIONI, MARIANA DE PAULI; DAMACENO ARAUJO, ANNA LUIZA; ARISTIZABAL ARBOLEDA, LADY PAOLA; PALMIER, NATALIA RANGEL; FONSECA, JESSICA MONTENEGRO; GOMES-SILVA, WAGNER; CAMILO MADRID-TROCONIS, CRISTHIAN; SILVEIRA, FELIPE MARTINS; MARTINS, MANOELA DOMINGUES; FARIA, KARINA MORAIS; PRADO RIBEIRO, ANA CAROLINA; BRANDAO, THAIS BIANCA; LOPES, MARCIO AJUDARTE; PAES LEME, ADRIANA FRANCO; MIGLIORATI, CESAR AUGUSTO; SANTOS-SILVA, ALAN ROGER. Tumor safety and side effects of photobiomodulation therapy used for prevention and management of cancer treatment toxicities. A systematic review. Oral Oncology, v. 93, p. 21-28, JUN 2019. Web of Science Citations: 1.

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