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Could ozone gas soothe cancer Patients' painful mouth sores?

NCT ID NCT07491536

Symptom relief Sponsor: University of Pavia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether applying medical ozone gas to mouth sores can reduce pain and severity in people undergoing radiation or chemotherapy for head and neck cancer. Fifty participants will receive ozone therapy, and half will also use a special toothpaste and mouthwash at home. The goal is to see if these treatments help people eat, drink, and continue cancer therapy with less discomfort.

What this could mean

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

Active substance
gas ozone therapy
What this could lead to
If it works, this could offer a simple, non-drug way to reduce mouth sore pain and help people continue cancer treatment without delays.
What could go wrong
This is a small, early-stage trial with only 50 people. Ozone therapy is not yet proven for this use, and results may not apply to everyone. Side effects are possible but not well-studied.

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 50 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 * Confirmed diagnosis of radio- and/or chemotherapy-induced oral mucositis, grade 1-3 according to the WHO Oral Toxicity Scale * Undergoing oncologic treatment for solid malignancies, particularly head and neck cancers * Clinically stable general health condition (ASA physical status I-III) * Ability to understand and comply with study procedures, including domiciliary treatment and questionnaire completion * Written informed consent provided Exclusion Criteria: * Oral mucositis grade 4 according to the WHO Oral Toxicity Scale * Active fungal or bacterial oral infections (e.g., candidiasis, ulcerative stomatitis) * Traumatic ulcers, non-oncologic mucositis, or concomitant oral mucosal diseases (e.g., lichen planus, pemphigus, graft-versus-host disease) * Ongoing head and neck radiotherapy with cumulative dose \>70 Gy or completion within 7 days prior to enrollment * Use within 14 days prior to enrollment of mouthwashes, sprays, or gels containing hyaluronic acid, ozone, aloe vera, or similar bioactive agents * Systemic or topical therapies known to interfere with salivary function or mucosal healing (e.g., anticholinergics, tricyclic antidepressants, diuretics) * Known allergy or hypersensitivity to components of the oral care products or materials used during ozone therapy * Severe or uncontrolled systemic diseases (including hepatic, renal, respiratory, or cardiac insufficiency) * Severe immunosuppression or neutropenia (neutrophils \<1,000/mm³) * Pregnancy or breastfeeding * Alcohol or substance abuse, or any condition that may compromise adherence to the protocol * Inability to attend scheduled follow-up visits through Day 30

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced oral mucositis head and neck neoplasm Head and Neck Neoplasms stomatitis Xerostomia

As listed by the trial registrant

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

Chemotherapy induced oral mucositis Head and neck neoplasms Oral mucositis

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

  • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

    RECRUITING

    Pavia, Lombardy, 27100, Italy

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