"mucositis, stomatitis"
Conditions
Interventions
Experimental group or intervention: composed of 30 participants, who will receive the gel with polihexanide (substance test). Control group comprised 30 participants who will receive the gel without p
Drug
D27.505.954
Sponsors
Universidade Estadual de Feira de Santana
Universidade Estadual de Feira de Santana
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Will be allocated to study cancer patients treated with any chemotherapeutic agent and / or radiotherapy in cervicofacial fields; aged over 18; treated in UNACON; who didn't have treatment for mucositis previously; that having read, understood and signed the Free and Clarified Consent Term (FCCT); and present oral mucositis or injury as a result of cancer treatment.
Exclusion criteria
Exclusion criteria: They will be excluded from the study: patients who refuse to participate in the study; under 18; already in treatment of mucositis; with an allergy to some component of the substances being applied in the study; who refuse to perform subsequent oral assessments; to discontinue the antineoplastic treatment for a period equal to or greater than 8 days; to suspend the use of the substances analyzed in the study; who are hospitalized terminally ill cancer; preventing the oral evaluations, and patients who come to death.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of oral mucositis within 8 or 15 days,after initiation of treatment. The method to be used to verify the expected outcome will be made by clinical evaluations (signs and symptoms) from the 1st day of applying the gel, according to the WHO classification criteria. Absence will be considered when the classification of mucositis match the grade 0 (Clinical signs of mucosa within normal limits and without painful symptoms of reports by patients). | — |
Secondary
| Measure | Time frame |
|---|---|
| Regression of oral mucositis within 8 or 15 days, after initiation of treatment. The method to be used to verify the expected outcome will be made by clinical evaluations (signs and symptoms) from the 1st day of applying the gel, according to the WHO classification criteria. Example: IV degree of regression to grade III. (The patient has ulcers, however, reports the possibility to feed orally via liquid foods.) | — |
Countries
Brazil
Contacts
Public ContactAna Paula;Márcio do Nascimento Andrade;Oliveira
Universidade Estadual de Feira de Santana;Universidade Estadual de Feira de Santana
Outcome results
None listed