Head and neck cancer (HNC) are among the most frequent malignancies in the world. The main treatment modalities for HNC are surgical excision, radiotherapy (RT), and chemotherapy (CT). Severe oral sequelae such as oral mucositis (OM), dysgeusia, opportunistic infections, trismus, and xerostomia/hyposalivation can affect HNC patients due to oncological treatment with RT and QT. Photobiomodulation therapy (PBMT) with an intraoral low-power laser has been studied as an excellent tool in the management of OM and xerostomia and thus improves the tolerability of RT in the head and neck region. The aim of this multicenter, randomized, single-blind clinical trial is to compare the effects of two photobiomodulation protocols (intraoral application low-level laser and defocused extraoral application of high-power laser) in the management of oral mucositis (OM) and xerostomia in head and neck cancer patients undergoing radiotherapy (RT). It is expected defocused extraoral high-power photobiomodulation shows results as good as intraoral photobiomodulation on the management of oral mucositis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
132
Light therapy for the management of oral side effects related to radiotherapy, mainly in the decrease of oral mucositis (OM) rates and OM severity, healing of OM ulcers and pain relief.
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGOral mucositis
The measurement of mucositis will be performed daily from the first day of the radiotherapy sessions until healing by a blinded observer. Mucositis will be scored according to World Health Organization criteria: grade 0 (none), grade I (oral soreness, erythema), grade II (oral erythema, ulcers, solid and liquid diet tolerated), grade III (oral ulcers, liquid diet only), and grade IV (oral alimentation impossible).
Time frame: 18 months
Oral mucositis
The measurement of mucositis will be performed daily from the first day of the radiotherapy sessions until healing by a blinded observer. Mucositis will be scored according to the National Cancer Institute (NCI) scale (NCI - Common Terminology Criteria for Adverse Events) will be performed: grade I mucosal erythema), grade II (patchy ulcerations with pseudomembranes), grade III (confluent ulcerations or pseudomembranes, bleeding with minor trauma), and grade IV (tissue necrosis, significant spontaneous bleeding).
Time frame: 18 months
Ulcerated oral mucositis
Oral mucosal sites affected by ulcerated oral mucositis will be recorded.
Time frame: 18 months
Xerostomia
A subjective evaluation will be performed daily by a classification proposed by Eisbrush et al., 2003: grade 0 (none), grade I (), grade II (oral erythema, ulcers, solid and liquid diet tolerated), grade III (oral ulcers, liquid diet only), and grade IV (oral alimentation impossible).
Time frame: 18 months
Hyposalivation
An objective evaluation will be performed weekly by measurement and weighing of non-stimulated and stimulated salivary flow (ml/min) as proposed by Eisbrush et al., 2003.
Time frame: 18 months
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