Copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy

NCT06708702 | Withdrawn Phase 2 DMC

• 1 other identifier: 76178323.4.0000.5274
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy; Oral Mucositis; Oral Mucositis (Ulcerative) Due to Radiation; Oral Mucositis Due to Radiation

Keywords

oral mucositis; radiotheraphy; copaiba; low power laser theraphy

Outcome Measures

Primary Outcomes (1)

• Oral mucositis ulcers in tumoral area

  To evaluate the incidence of oral mucositis (ulcers) in the tumor area in patients with oral cancer undergoing radiotherapy using copaiba-based mouthwash

  From date of randomization until the date of first documented ulcer or date of last RT session/ mouthwash use day, whichever came first, assessed up to 7 weeks

Secondary Outcomes (10)

• Mouthwashs safety

  From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks

• Oral Mucositis (OMS)

  From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks

• Oral Mucositis ulcers (Sonis)

  From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks

• Oral Mucositis erithema (Sonis)

  From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks

• Oral Mucositis (Sonis)

  From date of randomization until the date of last RT session/ mouthwash use day, assessed up to 7 weeks

Study Arms (2)

Copaíba

EXPERIMENTAL

Drug: Copaíba mouthwash

Placebo

PLACEBO COMPARATOR

Drug: Placebo mouthwash

Interventions

Copaíba mouthwash DRUG

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.

Copaíba

Placebo mouthwash DRUG

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.

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years or older;
• Patients enrolled at INCA diagnosed with malignant neoplasms located in the oral cavity or oropharynx with an extension of the lesion to the oral cavity (IDC-10 C01 to C06 or IDC10); with the indication of exclusive RT (using the Intensity Modulated Radiotherapy (IMRT)/ Volumetric Modulated Arcotherapy (VMAT) technique) or combined with surgery and/or CT;
• Patients with expected RT doses between 50 and 70Gy;
• Patients capable of understanding and adhering to the protocol;
• Patients capable of performing the oral hygiene protocol;
• Patients who, after the information and instructions, can provide the free and informed consent form.

You may not qualify if:

• Patients who are receiving drugs for the treatment and/or prevention of OM;
• Patients undergoing RT with planning that excludes the oral cavity from the irradiation field;
• Patients who report any allergy to CPB-based compounds.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (2)

Instituto Nacional de Cancer, Brazil

Rio de Janeiro, Rio de Janeiro, 20231050, Brazil

Location

Instituto Nacional de Cancer

Rio de Janeiro, Rio de Janeiro, 20231050, Brazil

Location

MeSH Terms

Conditions

Stomatitis; Ulcer

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blind to the group in which they are included, as will the study team. The non-blind team will be composed of the pharmacy team, that will be responsabli for the randomization and for dispensing of the investigational product/placebo.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: This is a phase II, randomized, placebo-controlled, double-blind study in a single institution, to evaluate the effectiveness of copaiba-based mouthwash in preventing oral mucositis in the tumor area in patients with oral cancer undergoing RT alone or in combination with CT. The participant will be randomized 1:1 to the study groups in a stratified manner according to the oncological treatments to which the patient will be subjected, according to the groups: exclusive treatment with RT and treatment with RT associated with CT. Randomization will be carried out using the REDCap® program by a non-blinded pharmacist, trained for this role. Participants\' daily care (outcome assessment) will begin on the first day of RT, and continue until the end of it, regardless of whether the patient has already reached the study\'s primary outcome or not.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 27, 2024
• Study Start: January 17, 2025
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)