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Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy
Sponsor: Instituto Nacional de Cancer, Brazil
Summary
This study aims to propose an alternative and auxiliary methodology for the prevention and treatment of Oral Mucositis (OM) in patients undergoing radiotherapy or radio and chemotherapy for head and neck neoplasms through the use of copaiba-based mouthwash, since the treatment that currently has proven efficacy for the prevention of OM(Low Power Laser Therapy) cannot be applied in tumor regions due to the risk of stimulating the tissue proliferation of malignant cells.
Official title: Phase I Study of Multiple Ascending Dose, to Investigate the Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2021-05-11
Completion Date
2026-12
Last Updated
2026-01-08
Healthy Volunteers
No
Interventions
Copaiba
A 10% and 15% aqueous solution of copaiba (Copaifera Officinalis Resin) manufactured by Interativo Farmácia de Manipulação will be used, under the formula: 10% copaiba oil (Copaifera Officinalis Resin) and 15% liquid mint aroma 5% , tween 80 1%, Aqueous solution (Distilled water + 0.1% Nipagin) qsp 100%.
Locations (1)
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, Brazil