Effectiveness of Photobiomodulation Protocols in Radiation-induced Oral Side Effects in H&N Cancer Patients
132 patients around the world
Available in Brazil
Radiotherapy (RT) and chemotherapy-induced oral side effects, as oral mucositis, and
xerostomia are extremely challenging for professionals in the supportive care for head and
neck squamous cell carcinoma (HNSCC) patients. There is a substantial evidence about the
benefits of photobiomodulation in the management of these oral side effects, mainly in the
decrease of oral mucositis (OM) rates and OM severity, healing of OM ulcers and pain relief
by intraoral low-level lasers. However, new parameters as extraoral applications by defocused
high-power lasers have been investigated to improve the OM outcomes, the patients'
complaints, and the experience in the clinical assistance by professionals. Thus, 132 H&N
cancer patients will be, globally and simultaneously, randomized according to clinical stage
of head and neck cancer, type of treatment (isolated RT or RT and QT), type of RT (RTC3D or
IMRT) and center involved (A.C. Camargo Cancer Center or State of São Paulo Cancer Institute
or Porto Alegre Clinics Hospital). The randomized patients can be allocated into two groups:
Group I: intraoral photobiomodulation with low level laser therapy (660nm, 100 mW, 10 J/cm2,
3 s/point) and Group II: extraoral photobiomodulation with high level laser therapy (810 +
980 nm, 1000 mW, 6.11 J/cm2, 30 s/point). PBMT will be performed daily, 5 times per week
during the radiotherapy or until wound healing of OM lesions by a trained professional. Oral
mucositis, pain, xerostomia, dysphagia, dysgeusia, oral functions, labial hydration and
radiodermatitis will be evaluated daily. Salivary flow and trismus will be assessed weekly,
and two questionaries (OHIP-14 and Vanderbilt) will be assessed on the first day of RT, on
the middle of RT regimen, on the final of RT regimen and three months later RT sessions.
Federal University of Rio Grande do Sul
1Research sites
132Patients around the world
This study is for people with
Head and neck cancer
Requirements for the patient
To 90 Years
All Gender
Medical requirements
Sites
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Recruiting
Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903