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

NCT05308732 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Head and Neck Neoplasms
  • Mucositis Oral
  • Radiotherapy; Complications

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%.

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2025-09-07
Completion
2026-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05308732 on ClinicalTrials.gov