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

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-4w4swx
• Date of registration: 20/01/2020
• Prospective Registration: No
• Primary sponsor: Alan Roger Roger dos Santos Silva
• Public title: Oncological safety of extraoral photobiomodulation in patients with oral and oropharyngeal squamous cell carcinoma
• Scientific title: Oncological safety of extraoral photobiomodulation in patients with oral and oropharyngeal squamous cell carcinoma - PBM-OM Photobiomodulation for oral mucositis
• Date of first enrolment: 28/11/2019
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-4w4swx
• Study type: Intervention
• Study design: Four-arm, double-blind, randomized controlled, phase III clinical trial of prevention.
• Phase: 3

Countries of recruitment

Brazil

Contacts

• Name: Alan Roger Santos Silva
• Affiliation: Faculdade de Odontologia de Piracicaba

Key inclusion & exclusion criteria

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;

Age minimum: 18Y
Age maximum: 85Y
Gender: -

Health Condition(s) or Problem(s) studied

Mucositis

Intervention(s)

The patients will be divided into two groups: extraoral prophylactic photobiomodulation (n =40) and extraoral placebo/control photobiomodulation (sham laser= 40).
Patients recruited to the prophylactic photobiomodulation group 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 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 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 Terminology Criteria for Adverse Events and WHO 1975)

E02.594.540

Primary Outcome(s)

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(s)

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.

Source(s) of Monetary Support

Fundação de Amparo a Pesquisa do Estado de São Paulo

Secondary Sponsor(s)

Faculdade de Odontologia de Piracicaba

Instituto do Câncer do Estado de São Paulo

Results

• Results available: Yes
• Date Completed: 31/12/2022