Effectiveness of Photobiomodulation Protocols in Radiation-induced Oral Side Effects in H&N Cancer Patients
Mucositis, Xerostomia, Hyposalivation
About this trial
This is an interventional prevention trial for Mucositis focused on measuring mucositis, xerostomia, photobiomodulation, head and neck cancer, taste disorders, trismus
Eligibility Criteria
Inclusion Criteria:
- Patients with a diagnosis of cancer in the oral cavity and oropharynx any clinical stage based on TNM staging of head and neck cancer;
- Patients who received oral care prior to oncological treatment;
- Patients who will receive conformational radiotherapy (RT-C3D) or Intensity-modulated radiotherapy (IMRT) from 50 Gy to 70 Gy (primary radiation field) in daily doses of 1.8-2, 12 Gy divided five times per week (from Monday to Friday), totalizing 6 to 7 weeks of treatment. They may receive exclusive RT or with chemotherapy concomitant with cisplatin (100 mg/m2 every 21 days or 50 mg/m2 per week);
- Patients feeding orally or by parenteral nutrition;
- Patients who agree to participate in the study after reading, filling, and signing the Consent Form for Participation in Clinical Research.
Exclusion Criteria:
- Patients who develop head and neck radiodermatitis and for this reason interrupt the survey;
- Patients who do not appear in four or more PBMT or RT sessions.
Sites / Locations
- Federal University of Rio Grande do SulRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Intraoral photobiomodulation protocol
Extraoral photobiomodulation protocol
Patients will receive the PBMT from the first day of RT, 5 times a week (Monday to Friday), for 6 to 7 weeks, or until there are no more mucositis lesions, just before the RT session. Intraoral protocol will utilize a low-level laser device (MMOptics Ltda, Sao Carlos, Sao Paulo, Brazil) with wavelength 660nm, power 100 mW, spot 0.03 cm², dose 10 J/cm², and time 3 seconds. The irradiations will be punctual and in a contact form, with 1 cm between the points, perpendicular to the oral mucosa, avoiding the tumor site and will be performed: 6 points on the labial mucosa (3 in the upper and 3 in the lower), 2 points on the labial commissure (1 on the right and 1 on the left), 8 points on the jugal mucosa (4 on the right and 4 on the left), 8 points on the lateral border of the tongue (4 on the right and 4 on the left), 5 points on the ventral tongue (2 on the right, 2 on the left side and 1 point on the apex), 4 points on the oral floor (2 on the right and 2 on the left side).
Patients will receive the PBMT from the first day of RT, 5 times a week (Monday to Friday), for 6 to 7 weeks, or until there are no more mucositis lesions, just before the RT session. Extraoral protocol will utilize a defocused high-level laser device (Gemini® Diode Laser - UltraDent) with wavelength 810 + 980 nm, power 1 W, spot 4.91 cm², dose 6.11 J/cm², and time 30 seconds. The irradiations will be punctual and in a contact form, perpendicular to the skin, avoiding the tumor site and will be performed: 5 points on the face (2 on both right and left cheeks, 2 points on both right and left parotid gland region and 1 on the lip); 5 points on the neck area (1 point on the sublingual gland region, 2 points on the right and left submandibular spaces and 2 points on the neck nearby lymphatic chain).