Changes in saliva secretion
Conditions
Interventions
Sham Group (Control): 41 patients being treated for head and neck cancer will answer a quality of life questionnaire consisting of 15 questions for xerostomia on the date of the first consultation (N0
E07.632.490
E05.478.566.350.170
Sponsors
Roberta Mariano de Carvalho e Silva
Pontifícia Universidade Católica de Campinas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteer patients; diagnosed with head and neck SCC; older than 18 years; in the 1st week of treatment with curative radiotherapy associated or not with chemotherapy.
Exclusion criteria
Exclusion criteria: Patients under 18 years of age; intubated; who did not start radiotherapy or chemoradiotherapy; palliatives for cancer treatment; with total loss of the maxilla or mandible due to the tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate xerostomia through the answer method of the Quality of Life Questionnaire developed and validated by the University of Michigan. A 20% reduction in the mean scores on the Questionnaire between the beginning and end of treatment will be considered clinically relevant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the salivary flow in a sub-sample of 15 patients per group at the beginning and at the end of the treatment by means of stimulated and non-stimulated sialometry in order to identify an increase, reduction or no alteration in the saliva secretion of the recruited patients. A 20% increase in the final salivary flow of patients will be considered clinically relevant;Quantify Mucin 5B and sIgA from the same sub-sample using the Enzyme-Linked Immunosorbent Assay (ELISA) at the beginning and end of treatment to identify increase, reduction or no change in substances. A 20% increase or decrease in the final amount of substances will be considered clinically relevant.;Measuring periodontal disease through the Periogram exam, which assesses the presence of periodontal disease by probing each tooth, and the DMFT index, which consists of the quantification of the total number of decayed, missing and filled teeth divided by the total number of teeth present in each patient, from the same sub-sample in order to correlate with the primary outcome of this study. It will be considered clinically relevant a 20% increase or reduction in the periodontal disease indicators evaluated in the Periogram and in the DMFT indexes in the final evaluation of the patients. | — |
Countries
Brazil
Contacts
Public ContactRoberta;Sérgio Silva;Pinheiro
;
Outcome results
None listed