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Amazon tree resin mouthwash tested against painful transplant side effect

NCT ID NCT07810530

Prevention Sponsor: Instituto Nacional de Cancer, Brazil Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing whether a mouthwash made from copaiba oil, combined with low-level laser therapy, can prevent oral mucositis in people undergoing autologous hematopoietic stem cell transplantation. Oral mucositis is a common and painful side effect of the high-dose chemotherapy used before transplant. In this phase II trial, 76 participants will be randomly assigned to receive either the copaiba mouthwash or a placebo four times a day, along with daily laser sessions, until their immune cells recover. The study measures safety and how well the treatment reduces the incidence and severity of mouth sores.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A mouthwash made from copaiba oil, a resin from Amazonian Copaifera trees, given alongside low-level laser therapy
What this could lead to
If it works, this could offer a plant-based, easy-to-use mouth rinse that helps prevent painful mouth sores during stem cell transplants.
What could go wrong
This is a phase II trial with 76 people, so it cannot prove the mouthwash works on its own. The copaiba rinse may not beat a placebo, and some people could find the taste or weekly use unpleasant.

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.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

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

12 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 12 years or older; * Patients indicated for autologous HSCT; * Patients with intact oral mucosa on the first day of conditioning; * Patients able to understand and adhere to the protocol; * Patients able to perform the oral hygiene protocol; * Patients who, after receiving information and instructions, can provide free and informed consent (ICF) and assent forms. Exclusion Criteria: * Patients currently receiving drugs for treatment and/or prevention of oral mucositis (OM); * Patients who had HSCT indicated but whose procedure was canceled for any reason; * Patients undergoing a second autologous HSCT; * Patients reporting any allergy to copaiba-based compounds.

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced oral mucositis stomatitis ulcer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oral mucositis Oral mucositis (ulcerative) due to antineoplastic therapy Oral mucositis due to chemotherapy Oral mucositis in patients undergoing HSCT

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Instituto Nacional de Cancer, Brazil

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, Brazil

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