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ACTIVE NOT RECRUITING
NCT05308732
PHASE1

Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy

Sponsor: Instituto Nacional de Cancer, Brazil

View on ClinicalTrials.gov

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

DRUG

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