Clinical Research Directory
Browse clinical research sites, groups, and studies.
Copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy
Sponsor: Instituto Nacional de Cancer, Brazil
Summary
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.
Official title: Phase II Study to Evaluate the Effectiviness of copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2025-01-17
Completion Date
2026-01-07
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Copaíba mouthwash
A 15% aqueous solution of copaíba (Copaifera Officinalis Resin) manufactured by Interativo Farmácia de Manipulação will be used, under the formula of copaíba oil (Copaifera Officinalis Resin) 15%, liquid mint aroma 5%, tween 80 1%, aqueous solution (Distilled water + Nipagin 0.1%) qsp 100%. Patients will receive the solution once a week. They will be instructed to shake the bottle before use for homogenization, to use 10mL of the solution for each mouthwash (which should be measured in the 10mL measuring cup that comes with each bottle), 4 times a day, rinsing vigorously for 1 minute and discarding all the solution after use.
Placebo mouthwash
Placebo will be used, under the formula of liquid mint flavor 5%, Nipagim 0.1%, and distilled water qsp 60 ml, packed in packaging compatible with that of the product under investigation, maintaining the same physical characteristics to maintain blinding. The product will be stored at room temperature and stored in the INCA pharmacy. Patients will receive the solution once a week. They will be instructed to shake the bottle before use for homogenization, to use 10mL of the solution for each mouthwash (which should be measured in the 10mL measuring cup that comes with each bottle), 4 times a day, rinsing vigorously for 1 minute and discarding all the solution after use.
Locations (2)
Instituto Nacional de Cancer, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, Brazil