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Amazonian tree oil may soothe radiation mouth sores in cancer patients

NCT ID NCT05308732

Symptom relief 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests whether a mouthwash made from copaiba, a natural oil from the Amazon, can safely help prevent and treat painful mouth sores caused by radiation therapy in 20 adults with head and neck cancer. Researchers will find the highest safe dose and measure pain levels. The goal is to offer an alternative when standard laser therapy cannot be used on tumor areas.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

May 2021

Expected to finish

Dec 2026

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

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: * Age ≥ 18 years old. * Patients enrolled at INCA with a diagnosis of cell carcinoma squamous, adenoid cystic carcinoma, mucoepidermoid carcinoma, carcinoma of acinar cells, low-grade polymorph adenocarcinoma, located in the oral cavity (ICD-10 C00 to C06); located in the oral cavity with the indication of exclusive radiotherapy (by IMRT/VMAT technique) or radiotherapy (by IMRT/ VMAT) associated with chemotherapy. * Performance status (PS) 0 or 1. * Patients with intact oral mucosa (except the tumor area) without color change and volume on the first day of treatment. * Patients able to cooperate with treatment. * Patients capable of performing the oral hygiene protocol. * Patients who after the information and instructions signed the term of free and informed consent of the patient in accordance with Resolution 466/12 of the National Health Council. Exclusion Criteria: * Patients who are receiving drugs for the treatment and/or prevention of oral mucositis. * Patients undergoing radiotherapy with planning that excludes the oral cavity of the treatment field. * Patients undergoing palliative radiotherapy. * Patients with cervical lymph node metastasis greater than 6cm (N3). * Patients who report any type of allergy to copaiba-based compounds. * Patients diagnosed with oral lichen planus.

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Conditions

The condition(s) this trial relates to.

head and neck neoplasm Head and Neck Neoplasms oral cavity cancer stomatitis prevention target

As listed by the trial registrant

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

Head and neck neoplasms Mucositis oral Radiotherapy; complications

Contacts and locations

Locations

  • Instituto Nacional de Cancer

    Rio de Janeiro, Rio de Janeiro, 20231-050, Brazil

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