Clinical Research Directory

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

Oral mucositis is the most significant acute toxicity of oral cavity radiotherapy. The available scientific evidence supports its preventive and therapeutic approach with low-level laser; however, this is unsuitable for tumor regions due to the risk of stimulating cellular metabolism. In this sense, an alternative treatment becomes necessary. Based on the preliminary results of the phase I study, a double-blind, randomized phase II study is suggested to evaluate the effectiveness of copaiba-based mouthwash in the prevention of oral mucositis in patients undergoing radiotherapy for oral cavity tumors. Patients will be randomized into 2 groups: A (copaíba) and B (placebo) and will use the mouthwash 4x/day. Each group will have 20 patients and be blind to the group in which they are included. They will be evaluated daily by a dental surgeon about oral mucositis, pain in the oral cavity and oropharynx, and dysphagia and will undergo daily laser therapy sessions, until the end of radiotherapy.

A Sequential Cohort Study Exploring GELCLAIR in the Management of Oral Mucositis in Patients Receiving Radical Radiation for Head and Neck Cancer

The goal of this clinical trial is to learn if Gelclair lubricant gel can help manage Oral Mucositis (OM) among Oropharyngeal and Oral cavity cancer patients receiving radiation treatment. The main questions it aims to answer are: 1. Does Gelclair help to manage the symptoms of OM and decrease its severity? 2. What do participants report as the maximum levels of pain and difficulties with swallowing? Researchers will compare Gelclair to the standard of care mouthwash treatment for OM (currently used for all patients with symptomatic OM) to see if Gelclair is helpful in managing oral mucositis. For the cohort using Gelclair, participants will: 1. Take the prescribed treatment for OM (Gelclair or Oncology mouthwash) once it is diagnosed, up to and including 4 weeks after radiation completes. 2. Complete a weekly survey about their OM symptoms up to and including 4 weeks after radiation completes. 2\. Report any problems experienced with prescribed treatment for OM (Gelclair or mouthwash). The same data will be collected for the cohort using standard of care mouthwash for comparison.