Copaíba mouthwash for preventing oral mucositis in cancer patients during radiotherapy
Phase II Study to Evaluate the Effectiviness of copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy
This study is testing if a copaíba mouthwash can help cancer patients undergoing radiotherapy avoid painful mouth sores.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Cancer, Brazil Government |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Rio de Janeiro and 1 other locations) |
| Trial ID | NCT06708702 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a copaíba-based mouthwash in preventing and treating oral mucositis in patients undergoing radiotherapy for oral cavity tumors. It is a double-blind, randomized phase II study where participants are assigned to either the copaíba mouthwash group or a placebo group, using the mouthwash four times a day. Patients will be monitored daily by a dental surgeon for symptoms of oral mucositis, pain, and dysphagia, and will also receive daily laser therapy sessions. The study aims to provide an alternative treatment method for oral mucositis, which is a common and painful side effect of radiotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with malignant neoplasms in the oral cavity or oropharynx who are scheduled to receive radiotherapy.
Not a fit: Patients currently receiving other treatments for oral mucositis or those whose radiotherapy does not include the oral cavity may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence and severity of oral mucositis, improving the quality of life for patients undergoing radiotherapy.
How similar studies have performed: Previous studies have shown promising results with copaíba in similar contexts, but this specific approach is novel in the setting of oral mucositis prevention during radiotherapy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Rio de Janeiro and 1 other locations
- Instituto Nacional de Cancer, Brazil — Rio de Janeiro, Brazil (Recruiting)
- Instituto Nacional de Cancer — Rio de Janeiro, Brazil (Not_yet_recruiting)
Study contacts
- Study coordinator: Héliton Antunes
- Email: hspindola@inca.gov.br
- Phone: 55 21 32076597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.