Oral mucositis
Conditions
Interventions
This is a randomized, controlled, parallel clinical trial with three arms, involving 168 adult participants diagnosed with oral mucositis grade =1 according to the WHO scale. Randomization will be per
Sponsors
Fundação Hospital Estadual do Acre - Fundhacre
Universidade Federal do Ceará
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes, aged 18 to 70 years, who started chemotherapy with cyclophosphamide, methotrexate, fluorouracil, and docetaxel and presented grade 1 or higher mucositis
Exclusion criteria
Exclusion criteria: Patients with mandibular immobilization or mechanical fixation that prevents visualization of the oral cavity; indigenous patients; foreign patients; patients allergic to propolis, pollen, or with allergic predisposition or atopy to components of bee honey; patients with concomitant inflammatory or degenerative oral disease; patients undergoing chronic therapy with steroids or immunosuppressants; unconscious or sedated patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe greater regression of oral mucositis in the group treated with Brazilian red propolis gel associated with low-level laser therapy, compared to the other groups, assessed by the variation in mucositis severity according to the WHO Oral Mucositis Scale between the beginning of the intervention (T1) and the seventh day of follow-up (T3), with the primary outcome defined as the difference in the proportion of participants who achieve grade 0 mucositis on day 7 of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in oral cavity pain intensity is expected, measured using a 0-to-10 numerical rating scale at T1, T2, and T3; a reduction in interference with diet, swallowing, and social function is also expected, assessed through a structured questionnaire | — |
Countries
Brazil
Contacts
Public ContactAntônio Arlen Freire
Universidade Federal do Ceará
Outcome results
None listed