Natural mouthwash aimed to soothe radiation mouth sores, but study never started
NCT ID NCT06708702
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study planned to test a mouthwash made from copaíba oil, a natural resin, to prevent and treat painful mouth sores (oral mucositis) in people with oral cancer undergoing radiation. The trial was set to include 40 patients, half using the copaíba mouthwash and half a placebo, four times a day. However, the study was withdrawn before any participants were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Copaíba oil (Copaifera Officinalis Resin) mouthwash
- What this could lead to
- If it had worked, this could have pointed toward a natural mouthwash to ease painful mouth sores during cancer treatment.
- What could go wrong
- The trial was withdrawn before enrolling any participants, so no results are available. Even if conducted, it was a small early-phase study with only 40 patients, so success was uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Started
-
Jan 2025
- Finished
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Jan 2026
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, 20231050, Brazil
-
Instituto Nacional de Cancer, Brazil
Rio de Janeiro, Rio de Janeiro, 20231050, Brazil
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Other studies related to the condition(s) this trial covers.
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