Head and Neck Neoplasms
Conditions
Interventions
Intervention: 25 patients undergoing radiochemotherapeutic treatment for head and neck cancer will receive, throughout the treatment, Photobiomodulatory Therapy with low-level laser daily (5 times a w
Active control: 25 patients undergoing radiochemotherapeutic treatment for head and neck cancer will receive, throughout the treatment, Photobiomodulatory Therapy with low power laser daily (5 times a
Sponsors
Faculdade de Odontologia da Universidade Federal de Goiás
Faculdade de Odontologia da Universidade Federal de Goiás
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients diagnosed with oral or oropharyngeal cancer; of both sexes; over 18 years old; treated with adjuvant or exclusive radiotherapy
Exclusion criteria
Exclusion criteria: Salivary gland tumors; Sjogren's Syndrome; infectious diseases of salivary glands; palliative radiotherapy; recurrent tumors; lymphoma diagnosis; diagnosis of melanoma; diagnosis of skin cancer; inability to self-care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome: degree of severity of oral mucositis, evaluated according to two instruments, the scale of the World Health Organization (WHO) that takes into account symptoms and ingestion capacity and that of the National Cancer Institute (NCI) of the United States of America that takes into account the size and depth of the lesions. Both evaluations will be carried out at the following times: first consultation before the start of radiotherapy (baseline) and after the 7th, 14th, 21st and 30th RT session by an evaluator blind to the participant's group, from digital photographs and registration the participant's ingestion capacity and symptomatology. World Health Organization (WHO) scale: 0 - no changes; 1 - burning and erythema; 2 - erythema, ulcers, solid diet; 3 - confluence of ulcers, liquid diet; 4 - impossibility of oral feeding. National Cancer Institute (American) (NCI) scale. 0 - no changes; 1 - mucosal erythema; 2 - pseudomembranous plaques smaller than 1.5 cm in diameter and not contiguous; 3 – confluent pseudomembrane plates, generally contiguous plates larger than 1.5 cm in diameter; 4- necrosis and/or deep ulceration or bleeding not induced by trauma. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome 1: The impact of oral health on quality of life will be evaluated in the following times: first consultation (baseline) and after the 7th, 14th, 21st and 30th RT session, using the OHIP-14 questionnaire. The OHIP-14 (Oral Health Impact Profile; Impact of oral health on quality of life) is a questionnaire consisting of 14 questions referring to functional limitation, physical pain, psychological discomfort, disability and physical, psychological and social incapacity. The statements were answered using the “Likert” scale (never: 0, rarely: 1, sometimes: 2, often: 3, and always: 4). Each item will be assigned a specific weight and a single index will be obtained from the sum of all OHIP-14 statements (Standard weighting method). The higher the score, the greater the impact on quality of life. It can reach a score between 0 and 56 points, and the lower the total score obtained, the smaller the impact on quality of life, therefore, the greater the satisfaction and well-being of the research participant. ;Secondary outcome 2: The report of oral mucositis symptoms will be evaluated at the times: first consultation (baseline) and after the 7th, 14th, 21st and 30th RT session, through the PROMS questionnaire (Patient Reporting Scale of Mucositis Symptoms Oral). The PROMS consists of ten questions about the symptoms reported by the patient with oral mucositis and to obtain the answers a visual analogue scale (VAS) is used. There are 10 questions with a variation of 0 – 10 in a 100 mm millimeter line without the markings, allowing the patient to mark in this spectrum between the extremes 0 cm (absence of the symptom) and 10 cm (the worst pain ever experienced by the patient, for example; or total absence of taste). Therefore, the score of each participant at each time evaluated can vary from 0 to 100 points and the higher the score, the worse the quality of life related to oral symptoms. The issues assessed are: mouth pain, difficulty speaking due to mouth | — |
Countries
Brazil
Contacts
Public ContactRodrigo;Associação de Combate dos Santos;Goiás - ACCG
Faculdade de Odontologia da Universidade Federal de Goiás ;Hospital de Câncer Araújo Jorge - Associação de Combate ao Câncer em Goiás
Outcome results
None listed