Radiodermatitis.
Conditions
Interventions
This is a randomized, controlled, triple-blind clinical trial with a quantitative approach that will follow the standards recommended by the Consolidated Standards of Reporting Trials. The population
Experimental 1: Calendula
Experimental 2: Chamomile), number of applications of the evaluation scale per patient (approximately seven evaluations), significance level (a = 0.05) and test power (1 – ß) = 0.80. Since this is an
B01.875.800.575.912.250.100.195
B01.875.800.575.912.250.100.141
Sponsors
Liga Norteriograndense Contra o Câncer
Liga Norteriograndense Contra o Câncer
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Be 18 years of age or older; both sexes; have a histologically proven diagnosis of head and neck neoplasia with indication for radiotherapy treatment associated with chemotherapy; no previous history of antineoplastic treatment; no previous history of radiotherapy in the same field/treatment site; intact and continuous skin in the head and neck region on the first day of radiotherapy treatment
Exclusion criteria
Exclusion criteria: Interrupt oncological treatment for a period longer than eight days; use of any other type of product on the skin in the area undergoing radiotherapy treatment; have any type of allergy or hypersensitivity to EFA, calendula or chamomile
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a significant reduction in the severity of radiodermatitis in patients with head and neck cancer undergoing radiotherapy associated with chemotherapy, measured by means of the Radiation Therapy Oncology Group acute toxicity grading scale and the intensity of pain assessed by the Visual Analogue Scale, with collections performed weekly during the treatment period until the end of the intervention protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe an improvement in the quality of life of the participants, assessed through complementary data on pain and general well-being, in addition to the comparison between the control and experimental groups regarding adherence to treatment and the presence of local adverse effects, with this information being obtained through standardized questionnaires and descriptive analysis of scientific reports | — |
Countries
Brazil
Contacts
Public ContactTâmara Medeiros da Silva
Liga Norteriograndense Contra o Câncer
Outcome results
None listed