Evaluation of the effect of Brazilian Propolis on mouth Inflammation (Mucositis) in patients undergoing treatment for Head and Neck Cancer
Phase 1
- Conditions
- 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).
- Registration Number
- RBR-76vd5wf
- Lead Sponsor
- niversidade de Franca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
Phase 1: individuals who have any type of disease, linked or not to cancer;
Phase 2: individuals in oncology, with chemotherapy other than cisplatin.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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