Copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy

Launched by INSTITUTO NACIONAL DE CANCER, BRAZIL · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a copaíba-based mouthwash to prevent and treat oral mucositis, a painful condition that can occur in patients receiving radiotherapy for oral cancer. Oral mucositis can make it difficult to eat and speak, so finding ways to manage it is very important. In this trial, patients will be randomly assigned to either use the copaíba mouthwash or a placebo (a mouthwash with no active ingredients) four times a day. The study involves 40 participants, all of whom will receive daily evaluations from a dental surgeon to monitor their oral health and any pain or swallowing difficulties they may experience.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with cancer in the oral cavity or throat that requires radiotherapy. They should be able to follow the study guidelines and provide informed consent. However, those currently taking medications for oral mucositis or who have allergies to copaíba products cannot participate. Throughout the study, participants will also receive daily laser therapy sessions as part of their treatment. This trial is currently recruiting participants, and it aims to provide important insights into better managing oral mucositis for cancer patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 18 years or older;
• • Patients enrolled at INCA diagnosed with malignant neoplasms located in the oral cavity or oropharynx with an extension of the lesion to the oral cavity (IDC-10 C01 to C06 or IDC10); with the indication of exclusive RT (using the Intensity Modulated Radiotherapy (IMRT)/ Volumetric Modulated Arcotherapy (VMAT) technique) or combined with surgery and/or CT;
• • Patients with expected RT doses between 50 and 70Gy;
• • Patients capable of understanding and adhering to the protocol;
• • Patients capable of performing the oral hygiene protocol;
• • Patients who, after the information and instructions, can provide the free and informed consent form.
• Exclusion Criteria:
• • Patients who are receiving drugs for the treatment and/or prevention of OM;
• • Patients undergoing RT with planning that excludes the oral cavity from the irradiation field;
• • Patients who report any allergy to CPB-based compounds.