Mucositis, Stomatitis, neoplasia chemotherapy session
Conditions
Interventions
The trial will be developed with patients undergoing docetaxel monotherapy chemotherapy treatment (Infusion continues intravenous) at a University Hospital.
The study will include 40 patients, 20 in e
Other
E02.258
Sponsors
Hospital das Clinicas de Ribeirão Preto
Faculdade de Odontologia de Ribeirão Preto
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients older than 18 years in the first cycle of chemotherapy with docetaxel.
Exclusion criteria
Exclusion criteria: It will be excluded from the study patients with indication or history of radiotherapy treatment; other chemotherapy regimens; active smokers in the last 90 days; patients with cancer lesions affecting the head and neck region; patients with clinically identified oral lesions or infections; patient with active periodontal disease in the immediate pre-Qt; patients who do not complete pre-QT dental preparation; carriers of autoimmune diseases; patients with infectious complications from any site; neurological or psychomotor alterations that hinder self-care, cryotherapy and / or response to questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall incidence of Oral Mucositis in the treatment and control group will be evaluated. The diagnosis of the presence of Oral Mucositis will be made through clinical examination, following the classification criteria for oral mucositis of the World Health Organization (Grade I onwards = presence of oral mucositis / Grade 0 = absence of oral mucositis). Times of assessment of this outcome: T0 (immediately before the first chemotherapy cycle), T2 (7 days after chemotherapy) and T3 (21 days after chemotherapy).;The severity of Oral Mucositis in the treatment and control group will be evaluated. The classification of severity of Oral Mucositis will follow the criteria defined by the World Health Organization (Grade III and IV will be considered severe mucositis). Times of assessment of this outcome: T0 (immediately before the first chemotherapy cycle), T2 (7 days after chemotherapy) and T3 (21 days after chemotherapy). | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory cytokines (TNF-alpha, IL-6, IL-beta) that will be evaluated in the blood and saliva of patients in the control and treatment group. The ELISA technique will be used. The variable used to analyze the expression of inflammatory mediators will be the delta between T0 and the other times The parameters are given by the ELISA test itself. Assessment times for this outcome: T0 (immediately before the first chemotherapy cycle), T1 (30 minutes after chemotherapy infusion), T2 (7 days after chemotherapy) and T3 (21 days after chemotherapy).;Oral Health Indexes will be collected in both the control and treatment groups. The CPO-D and PSR indices will be used according to the parameters established by WHO. The data will be used to characterize the sample. Evaluation times of this outcome: First dental appointment and T0 (immediately before the first chemotherapy cycle);Quality of life using the questionnaires: EORTC QLQ-C30, version 3.0, developed by the European Organization for Research and Treatment of Cancer Quality of Life and the Oral Mucositis Quality of Life (OMQoL) questionnaire. Patients' quality of life will be assessed according to the score and categorization recommended by each questionnaire. Parameters: -EORTC QLQ-C30 (Potuation from 0 to 100) In relation to the functional scales and global health status, higher scores are related to better quality of life; however, for the symptom scales, higher scores correspond to a greater presence of that symptom. There is no characterization by score range. -Mucositis Quality of Life (OMQoL): (Score 31 to 124). The higher the score, the worse the quality of life. There is no characterization by score range. Times of assessment of this outcome: T0 (immediately before the first chemotherapy cycle), T2 (7 days after chemotherapy) and T3 (21 days after chemotherapy).;Tolerability to cryotherapy. It will be evaluated using a questionnaire formulated by the researchers with the main adverse events reporte | — |
Countries
Brazil
Contacts
Public ContactThiago de Reis
Hospital das Clinicas de Ribeirão Preto
Outcome results
None listed