Oncological safety of extraoral photobiomodulation in patients with oral and oropharyngeal squamous cell carcinoma

Phase 3

• Conditions: Mucositis

• Registration Number: RBR-4w4swx
• Lead Sponsor: Alan Roger Roger dos Santos Silva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-20
• Study Completion: 2022-12-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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;
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;
Should receive at least 60 Gy in the primary radiation field;
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;

Exclusion Criteria

Patients with squamous cell carcinoma located in other topographies of the head and neck region;
Patients who did not receive dental treatment prior to radiotherapy (RT);
Patients who will be submitted to RT regimens different from those included in the inclusion criteria;
Patients whose demographic and clinicopathological information is not fully available in the medical records;

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
After radiotherapy (RT) 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 impact of 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.

Secondary Outcome Measures

Name	Time	Method
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). Analgesia will also be assessed.