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Natural mouthwash aimed to soothe radiation mouth sores, but study never started

NCT ID NCT06708702

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 However, the study was withdrawn before any participants were enrolled, so no results are available.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The trial was withdrawn before enrolling any participants, so no results are available.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

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.

Show the full entry requirements

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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