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Olive oil and betaine gel may ease radiation mouth pain

NCT ID NCT05635929

Symptom relief Sponsor: Mucosa Innovations, S.L. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a topical gel and mouthwash made from olive oil, betaine, and xylitol (XCM-OM118) to see if it can reduce severe oral mucositis (painful mouth sores) in head & neck cancer patients receiving radiation. The study will enroll 63 adults and track how many develop severe sores, as well as measure quality of life using patient questionnaires. The goal is to find a simple, non-drug way to ease a common and painful side effect of cancer treatment.

What this could mean

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

Active substance
XCM-OM118 (a gel and mouthwash made from olive oil, betaine, and xylitol)
What this could lead to
If it works, this could offer a simple, non-drug way to prevent severe mouth sores during radiation, improving quality of life for head & neck cancer patients.
What could go wrong
This is a small, early-phase trial with no control group, so results may not be definitive. The treatment may not reduce severe mucositis as hoped.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 63 people

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

Started

Oct 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: Acute Phase * Patients diagnosed with Head \& Neck cancer who will undergo radiotherapy (with or without concomitant chemotherapy) * Patients who are able to read, understand, and complete the questionnaire. * Patients over 18 years of age. Chronic Phase * Patients who have completed radiotherapy treatment at least 6 months before study enrollement. * Patients who are able to read, understand, and complete the questionnaire. * Patients over 18 years of age. Exclusion Criteria: Acute Phase * Patients who are unable to properly use the products. * Patients who do not consent to participate in the study. * Patients who were being treated for another type of cancer. Chronic Phase * Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia. * Patients who do not consent to participate in the study.

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced toxicity head and neck cancer Head and Neck Neoplasms mucositis Pain radiation injury Speech speech disorder stomatitis ulcer disease

As listed by the trial registrant

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

Chemotherapeutic toxicity Head and neck cancer Mucositis Oral mucositis Pain Quality of life Radiation toxicity SALIVA SPEECH

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

  • Mucosa Innovations S.L.

    RECRUITING

    Madrid, Madrid, 28023, Spain

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