Oral Mucositis
Conditions
Interventions
A randomized double-blind controlled Cross-over clinical trial will be carried out in individuals with cancer in the head and neck region. The sample size considered will be 30 individuals, including
that is, participants are randomized to sequences of interventions. In this way, each participant acts as his own control, which favors the control of confounding variables that threaten the internal
Sponsors
Universidade Federal de Goias
Associação de Combate ao Câncer de Goiás
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The study will include participants over 18 years of age; of both sexes; of any ethnicity; skin color; race; edentulous or not; with primary diagnosis of squamous cell carcinoma in the head and neck region; oral cavity; oropharynx; nasopharynx and larynx. Tumors should be classified into T3/N1; T3;N2 or T4 with N1; state N2 or N3; patients should also be indicated for RT, with or without chemotherapy; with a total dose of TR > 50Gy and daily minimum of 2Gy without history of previous RT in the region of interest or previous CT. Sociodemographic variables; like sex; age; skin color; ethnicity; marital status; city where you live; urban or rural sector; schooling; family history of cancer and occupation will be noted. Besides these; risk factors such as occupational exposure; alcoholism and smoking habits will also be recorded Sociodemographic variables, such as: sex, age, skin color, ethnicity, marital status, city where they live, urban or rural sector, education, family history of cancer and occupation will be pointed out. In addition to these, risk factors such as: occupational exposure, alcoholism and smoking habits will also be recorded.
Exclusion criteria
Exclusion criteria: Patients with tumors in salivary glands; patients with Sjögren's syndrome; patients with infectious diseases; individuals who will undergo palliative RT or with a history of previous cancer treatment. Individuals diagnosed with lymphoma; melanoma or skin cancer will also be excluded from the sample. In cases of death; withdrawal; If five or more consecutive TFBM sessions are missed, participants will also be excluded from the survey.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in the severity of oral mucositis during radiotherapy sessions verified by the assessment of quality of life (OHIP-14 questionnaire) and by the PROMS scale and clinical evaluations based on the WHO and NCI -USA scores, evaluated at intervals of ten days, that is, from baseline to the last radiotherapy session. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in the phenomenon of pain caused by oral mucositis evaluated in the period of seven weeks during radiotherapy treatment by the visual scale method of the visual analogue of pain and evaluation of the inflammatory response through the analysis of inflammatory cytokines using saliva will be measured and determined by the BD FACSCanto II flow cytometer test (BD Biosciences, San Jose, CA, USA) using the CBA human inflammatory cytokines kit (BD Biosciences) following the instructions recommended by the manufacturer during the seven-week period.;It is expected to find a reduction in the number of hospitalizations due to adverse effects during the radiotherapy treatment period of seven weeks, verified through the registration in the medical records and absences during the laser therapy and radiotherapy sessions, based on a quantitative analysis. | — |
Countries
Brazil
Outcome results
None listed