Occurrence and treatment of oral mucositis in subjects in the treatment of head and neck cancer

Not Applicable

Recruiting

• Conditions: mucositis, stomatitis; C06.405.205.798; C07.465.864

• Registration Number: RBR-6fs48y
• Lead Sponsor: niversidade Estadual de Feira de Santana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of oral mucositis within 8 or 15 days,after initiation of treatment. <br>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.<br>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 Outcome Measures

Name	Time	Method
Regression of oral mucositis within 8 or 15 days, after initiation of treatment. <br>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.<br>Example: IV degree of regression to grade III. (The patient has ulcers, however, reports the possibility to feed orally via liquid foods.)