Two groups of intervention participants: (1) individuals without any underlying pathology or disease for toxicity assessment (2) individuals being treated for head and neck cancer by chemotherapy and radiotherapy, for assessment of anti-inflammatory profile on oral mucositis (stomatitis).
Conditions
Interventions
Experimental group will present two phases of study. The first corresponds to 30 healthy individuals that will be stratified into Control Group, Shen Control and Intervention Group, with n = 10 / grou
Sponsors
Universidade de Franca
Fundação Santa Casa de Misericórdia de Franca
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Phase 1: Volunteers over 18 years old; in full health; Phase 2: Volunteers over 18 years old; in head and neck cancer treatment; in radiotherapy and chemotherapy treatment with cisplatin; with the presence of mucositis.
Exclusion criteria
Exclusion criteria: Phase 1: individuals who have any type of disease, linked or not to cancer; Phase 2: individuals in oncology, with chemotherapy other than cisplatin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-inflammatory action of 5% red propolis gel and reduction in the mucositis index with a decrease in the degree of mucositis = 0 according to the WHO classification. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the quality of life of individuals with mucositis, aiding in the ingestion of solid foods, increasing their nutritional supply; absence of opportunistic candidiasis | — |
Countries
Brazil
Contacts
Public ContactSilvio Almeida Junior
Outcome results
None listed