Xerostomia
Conditions
Interventions
A randomized double-blind clinical trial was carried out to compare changes in the salivary flow of patients undergoing treatment for head and neck cancer with radiotherapy, submitted to two different
Procedure/surgery
E07.632.490
E02.594.540
Sponsors
Próprio pesquisador
Universidade Federal de Pernambuco
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Patients with cancer of the head and neck (oral cavity, pharynx, larynx and occult primary) with indication of treatment with radiotherapy; Patients that the irradiation field must include all major salivary glands.
Exclusion criteria
Exclusion criteria: Patients younger than 18 years or incapacitated to answer questions; Initial tumors (T1 and T2) and limited to the larynx, other sites such as metastases and skin tumors; Indication of RT with palliative intent; Patients with Diabetes Melitus, autoimmune, infectious and collagen diseases. Patients who use drugs that may interfere with the salivary flow; Patients with trismus or limitation of mouth opening due to surgical sequelae.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1 It was expected that at D3, one month after the end of radiotherapy, patients belonging to the intervention group would have maintained an unstimulated salivary flow greater than 0.2 ml / min (grade 1) and lower degrees of xerostomia when compared to the placebo group, measured through unstimulated sialometry and the application of the xerostomia inventory.;Outcome found 1 The patients in the intervention group maintained an unstimulated salivary flow greater than 0.2 ml / min after one month of radiotherapy. They also maintained lower xerostomy inventory values ??than the control group for one month after completion, indicating less severe xerostomy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2 It was expected that patients in the intervention group had a lower prevalence of oral complications associated with hyposalivation than patients in the control group.;Outcome found 2 A lower prevalence of oral complications associated with hyposalivation (mucositis, fungal infections, dysphagia, oral pain) was observed in the intervention group when compared to the control group, confirming the expected outcome 2. | — |
Countries
Brazil
Contacts
Public ContactRaylane de Albuquerque
Universidade Federal de Pernambuco
Outcome results
None listed