Oral Plus Mouth Rinse in the management of Chemotherapy-Induced Oral Mucositis

INTERVENTION: 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 using a random number table. Both the researchers responsible for outcome assessments and the participants will be blinded to group allocation. Experimental group: 39 participants undergoing cytotoxic chemotherapy will receive laser photobiomodulation, along with Oral Plus mouth rinses three times a day for 63 days. Control group: 39 participants undergoing cytotoxic chemotherapy will receive laser photobiomodulation, along with a placebo mouth rinse three times a day for the same period. CONDITION: C07.465.864 Oral mucositis (ulcerative) PRIMARY OUTCOME: 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 OUTCOME: 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 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 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) Measure the total time during which oral mucositis lesions remain active Quantify the number of anatomical sites in the oral cavity affected by mucositis Record the occurrence of oral candidiasis and other opportunistic infections throughout the study 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