Oral mucositis (ulcerative)
Conditions
Interventions
This is a randomized, controlled, double-blind, two-arm clinical trial. A total of 78 participants meeting the eligibility criteria will be randomly assigned to one of the two intervention groups usin
E02.594.540
Sponsors
União Brasileira de Educação e Assistência
União Brasileira de Educação e Assistência
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants of both sexes; aged 18 years or older; diagnosed with solid or hematological malignant neoplasms and indicated for chemotherapy with cisplatin, cytarabine, bleomycin, etoposide, 5-fluorouracil (5-FU), doxorubicin, melphalan, busulfan, vincristine, daunorubicin, mercaptopurine, gemcitabine, cyclophosphamide, methotrexate, or capecitabine – these chemotherapeutic agents may be administered alone, in combination, or concurrently with other drugs, including immunotherapies and targeted therapies; chemotherapeutic agents administered orally, intravenously, subcutaneously, or intrathecally at intervals of no more than 21 days; capable of providing written informed consent, demonstrating full understanding of the study’s objectives, procedures, and potential risks; with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
Exclusion criteria
Exclusion criteria: Individuals who do not agree to participate or do not sign the Informed Consent Form (ICF); have a history of radiotherapy in the head and neck region; have a history of hypersensitivity or allergy to the components of the Oral Plus mouthwash; have severe systemic diseases such as hepatic or renal failure, uncontrolled autoimmune diseases, or other conditions that may interfere with participation or interpretation of the study results; are concurrently using other specific treatments for oral mucositis, such as medicinal mouthwashes or alternative therapies targeted at mucositis; are pregnant or breastfeeding; have participated in another clinical trial that may interfere with the results of this study within 30 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the mouthwash Oral Plus (Alora®, Porto Alegre, Brasil) in the prevention and/or reduction of the severity of oral mucositis induced by chemotherapy in patients with malignant neoplasms using the World Health Organization Oral Mucositis Scale with a minimum score of 0 and a maximum score of 4 with data collected before the beginning of the product use and at the end of three weeks of continuous use | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the interval between the start of oncologic therapy and the appearance of the first signs or symptoms of oral mucositis;Determine the severity of oral mucositis based on the World Health Organization (WHO) classification scale;Measure the total time during which oral mucositis lesions remain active;Quantify the number of anatomical sites in the oral cavity affected by mucositis;Evaluate the pain intensity associated with oral mucositis using the Visual Analog Scale (VAS);Measure the sensation of dry mouth using the Visual Analog Scale (VAS);Record the occurrence of oral candidiasis and other opportunistic infections throughout the study;Analyze the influence of oral mucositis on participants’ quality of life using the Oral Health Impact Profile-14 (OHIP-14) questionnaire;Assess patients' satisfaction with the use of the Oral Plus mouth rinse | — |
Countries
Brazil
Contacts
Public ContactMariana Simionovschi
Pontifícia Universidade Católica do Rio Grande do Sul
Outcome results
None listed