Oral Mucositis
Conditions
Interventions
E02774500
As a result of the sample calculation, the experimental and control subgroups should have 22 participants, consequently 44 in each group and a total sample of 132 patients.In the experimental subgroup
Radiation
Sponsors
Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Group 1: Patients with head and neck neoplasms undergoing radiotherapy;Group 2: Patients with head and neck neoplasms undergoing radiochemotherapy;Group 3: Patients with neoplasias of the gastrointestinal tract under chemotherapeutic treatment (Fluorpyrimidine).
Exclusion criteria
Exclusion criteria: Patients younger than 18 years;Presence of oral ulcerations or erosions;Cognitive deficits;Simultaneous participation in another clinical study;In long-term treatment with photosensitizing agents.Difficulty opening the mouth, such as trismus or maxillo-mandibular block.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower prevalence of oral mucositis, comparing the proportions between the experimental and control subgroup, a significance of 5% and a 95% confidence interval will be adopted. According to normality tests, parametric or non-parametric tests will be adopted To compare the proportions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Minor severity and pain of Oral Mucositis. The degree of Oral Mucositis will be assessed according to World Health Organization classification criteria and in relation to oral pain, patients will be assessed subjectively according to a Visual Analogue Scale. According to normality tests, parametric or non-parametric tests will be used to compare the means, a significance of 5% and a confidence interval of 95% will be adopted. | — |
Countries
Brazil
Contacts
Public ContactJanaina Cavalcanti
Universidade Federal de Pernambuco
Outcome results
None listed