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

NCT05308732 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 34635020.5.0000.5274
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Head and Neck Neoplasms; Mucositis Oral; Radiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  Evaluate the maximum tolerated dose of the aqueous copaiba solution.

  Through the use of the copaiba oil, an average of 6 to 7 weeks.

Secondary Outcomes (3)

• Acess rate of pain

  From baseline to the last day of copaiba use (day 33 to day 37).

• Acess rate of oral pain

  From baseline to the last day of copaiba use (day 33 to day 37).

• Incidence of Oral Mucositis

  From baseline to the last day of copaiba use (day 33 to day 37).

Study Arms (1)

Copaiba arm

EXPERIMENTAL

It will consist of the group of patients who will use copaiba mouthwash. It will be subdivided into 6 consecutive cohorts.

Drug: Copaiba

Interventions

Copaiba DRUG

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%.

Copaiba arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old.
• Patients enrolled at INCA with a diagnosis of cell carcinoma squamous, adenoid cystic carcinoma, mucoepidermoid carcinoma, carcinoma of acinar cells, low-grade polymorph adenocarcinoma, located in the oral cavity (ICD-10 C00 to C06); located in the oral cavity with the indication of exclusive radiotherapy (by IMRT/VMAT technique) or radiotherapy (by IMRT/ VMAT) associated with chemotherapy.
• Performance status (PS) 0 or 1.
• Patients with intact oral mucosa (except the tumor area) without color change and volume on the first day of treatment.
• Patients able to cooperate with treatment.
• Patients capable of performing the oral hygiene protocol.
• Patients who after the information and instructions signed the term of free and informed consent of the patient in accordance with Resolution 466/12 of the National Health Council.

You may not qualify if:

• Patients who are receiving drugs for the treatment and/or prevention of oral mucositis.
• Patients undergoing radiotherapy with planning that excludes the oral cavity of the treatment field.
• Patients undergoing palliative radiotherapy.
• Patients with cervical lymph node metastasis greater than 6cm (N3).
• Patients who report any type of allergy to copaiba-based compounds.
• Patients diagnosed with oral lichen planus.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Instituto Nacional de Cancer

Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil

Location

Related Publications (51)

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  BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The investigator will assign a unique number to the patient being evaluated to participate in the study. The patients included in the study will receive instructions on oral hygiene and the aqueous copaiba solution for mouthwash. The recruitment and design of the study will be carried out according to the "3 + 3" design (modified Fibonacci design) with the planned inclusion of 6 successive cohorts (of 3 patients) with different patients. Each cohort of patients will be closely monitored for one week before moving on to a new cohort. There will be no dose escalation in the same patient. The first 3 cohorts will use the mouthwash at 10%, 2, 3, and 4 times a day respectively. The last 3 cohorts will use the mouthwash at 15%, 2, 3, and 4 times a day respectively. If radiotherapy is interrupted for any reason and the patient is benefiting from using the mouthwash with copaiba, the patient will continue to perform the mouthwash.

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: April 4, 2022
• Study Start: May 11, 2021
• Primary Completion: September 7, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)