Oncological safety of photobiomodulation in cancer patients

INTERVENTION: Device Low‐Level Light Therapy The patients will be divided into four groups: intraoral prophylactic photobiomodulation (n = 30) and intraoral placebo/control photobiomodulation (sham laser, n = 30), extraoral prophylactic photobiomodulation (n = 30) and extraoral placebo/control photobiomodulation (sham laser= 30). Patients recruited to the prophylactic photobiomodulation groups will be submitted since the first day of RT to 5 weekly sessions of photobiomodulation, from Monday to Friday, during 6 to 7 weeks, immediately prior to the radiotherapy (RT) session. The intraoral prophylactic photobiomodulation parameters will be 660 nm length, 40 mw power, 10 J / cm2 energy density, energy per point of 0.4 J, spot size of 4 mm2 and application time of 10 s per point of the oral mucosa. The application will be performed in a punctual manner including all bilateral buccal mucosa extension, bilateral upper and lower fornix, upper and lower labial mucosa, lateral borders of tongue, tongue ventral surface and mouth floor. The extraoral prophylactic photobiomodulation parameters will be based on near infrared ‐ LED, for a total power of 1390 mW. The LED will be applied flat against the face and neck of the patient at five treatment sites: right side, center face, left side, left neck and right neck. The device will be applied for 60 s per location (50 mW/cm2 x 60 s = 3.0 J/cm2 for five locations). Patients recruited to the placebo/control photobiomodulation group will be submitted to laser sham sessions through intra and extraoral light emitting tips that will be adapted to the equipment during all RT sessions, following the same model and application protocols. All patients recruited for the study will be evaluated daily for the evaluation of the presence and oral mucositis grade (Common Terminolo CONDITION: Mucositis Mucositis ; Mucositis PRIMARY OUTCOME: During the radiotherapy (RT) period, all patients enrolled in the study will be evaluated daily for assessment of the presence and MO grade, following the Common Terminology Criteria for Adverse Events classification criteria published by the National Cancer Institute (NCI, version 4.0, 2010). Oral mucosal pain will be quantified daily through a visual analogue scale (VAS). After completion of treatment, patients will be assessed quarterly over the 18‐month period, totaling 6 evaluations. Evaluations will be based on clinical dental examinations and medical information available in electronic medical records that allow the characterization of the following cancer outcomes: local recurrence rates, development of second primary tumors, disease specific survival rate, and overall survival. SECONDARY OUTCOME: Characterization of the impact of intraoral and extraoral photobiomodulation on disease specific survival rate and overall survival (oncologic prognosis) of patients with oral cavity and oropharynx squamous cell carcinoma (SCC). And to contributing to the improvement of prophylactic protocols of extraoral photobiomodulation in patients with (SCC) of oral cavity and oropharynx. INCLUSION CRITERIA: Patients diagnosed with oral cavity (C02, C03, C04, C05, C06) or oropharyngeal (C10) squamous cell carcinoma; Patients with III/IV stage tumors according to the International Union Against Cancer (TNM) system; Patients that underwent dental treatment prior to the oncological treatment; Should receive at least 60 Gy in the primary radiation field; Patients who will be submitted to RT (radiotherapy) based on Elekta Synergy 6‐mV linear accelerators (Elekta AB, Stockholm, Sweden) with planning on conformational three‐dimensional basis or IMRT as a form of oncological treatment alone or in combination with surgery or chemotherapy; Demographic and clinicopathological information, including gender, age, habits (smoking and alcoholism), medical and family history, location of the primary tumor, clinical staging (TNM), and type of treatment are available in the medical records;