Oral mucositis (ulcerative)
Conditions
Interventions
This is a randomized, controlled, parallel, three-arm, triple-blind clinical trial with 75 participants (25 per group). Participants will be allocated by simple randomization, performed by an independ
Sponsors
Universidade Estadual do Oeste do Paraná
Hospital do Câncer Uopeccan
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older. Patients of both sexes. Patients with confirmed diagnosis of malignant neoplasm in the oral cavity. Patients undergoing chemotherapy or radiotherapy at the Uopeccan Cancer Hospital. Patients presenting with oral mucositis grade I to III according to the World Health Organization (WHO) classification. Patients using standard medications for mucositis management according to the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) guidelines. Patients who provide informed consent
Exclusion criteria
Exclusion criteria: Patients with malignant neoplasm in the hypopharynx, salivary glands, or lips. Patients with mucositis extending to the oropharynx or esophagus. Patients undergoing concomitant alternative therapies, such as biological agents or cryotherapy. Patients with severe comorbidities. Patients using medications not included in the guidelines of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). Patients undergoing antineoplastic treatment not exclusively at the Uopeccan Cancer Hospital
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome: A reduction in the severity of oral mucositis is expected, assessed by the World Health Organization (WHO) oral mucositis classification, using the percentage of patients classified in each severity grade (0 to 4), recorded in weekly evaluations during the follow-up period (days 0, 7, 14, 21, and 28 after treatment initiation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome: A decrease in pain intensity associated with oral mucositis is expected, assessed using the Visual Analogue Scale (VAS) from 0 to 10, based on the mean pain scores, recorded daily during treatment and at the same time points as the primary outcome;Expected outcome: An improvement in quality of life is expected, assessed by the validated EORTC QLQ-C30 questionnaire, using total and domain scores, recorded at baseline, mid-treatment, and at the end of follow-up;Expected outcome: The incidence of adverse events and therapy-related complications is expected to be verified, monitored by the number and type of events in each group, throughout the treatment period and up to 7 days after its completion;Expected outcome: The therapeutic potential of ozone therapy as an alternative or adjuvant treatment is expected to be demonstrated, assessed by the combined clinical response including improvement of mucositis, pain reduction, and quality of life improvement, using a composite index or comparative descriptive analysis between groups, recorded at the end of follow-up | — |
Countries
Brazil
Contacts
Public ContactMaria Ritha Colognese
Universidade Estadual do Oeste do Paraná
Outcome results
None listed