Stomatitis Low-Level Light Therapy
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. A total of 70 people with head and neck cancer undergoing radiotherapy or chemoradiotherapy, who meet the eligibility criteria an
PROT), which will be administered in a 5ml dose for 30 seconds every day during treatment. Participants will complete three questionnaires: OHIP-14 (Oral Health Impact Profile-14), PROMs (Patient-Repo
Sponsors
Associação de Combate ao Câncer em Goiás
Faculdade de Odontologia da Universidade Federal de Goiás
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants of both genders; over 18 years of age; with head and neck cancer; who will undergo radiotherapy or chemoradiotherapy with a minimum total dose of 60 Gy and a minimum daily dose of 2 Gy; performance status score between 0 and 2
Exclusion criteria
Exclusion criteria: Participants with salivary gland tumors; those with Sjögren's syndrome; those with infectious diseases; individuals undergoing palliative radiotherapy; those with a history of previous cancer treatment in the head and neck region; participants diagnosed with lymphoma; those diagnosed with melanoma or skin cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The intervention group is expected to present with less frequent and less severe oral mucositis, which will be assessed through clinical photographs that will be reliable in terms of severity according to the scales of the National Cancer Institute (NCI) and the World Health Organization (WHO) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the perception of oral mucositis symptoms using the PROMs (Patient-Reported Outcome Measures) questionnaire ;Analyze the occurrence of radiotherapy interruptions considering the causes, number of times, and duration of the interruption;To comparatively measure salivary levels of pro- and anti-inflammatory mediators between groups according to the established therapeutic protocol using flow cytometry assay (CBA - cytometric bead array);To describe the sociodemographic and clinical-pathological profile of the selected participants;To investigate adherence to treatment based on the therapeutic protocols established for each group using the MMAS-8 (Morisky Medication Adherence Scale 8) questionnaire ;To assess the impact of therapeutic protocols on quality of life using the OHIP-14 (Oral Health Impact Profile 14) questionnaire | — |
Countries
BR
Contacts
Public ContactElismauro de Mendonça
Faculdade de Odontologia da Universidade Federal de Goiás
Outcome results
None listed