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Ozone gas may ease chemo nerve pain, small trial hopes

NCT ID NCT04299893

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study tests whether adding ozone therapy to standard care can reduce nerve pain caused by chemotherapy. 42 adults with cancer and persistent nerve pain will receive either ozone or oxygen gas via rectal insufflation for 16 weeks. The main goal is to see if pain and quality of life improve, and whether the treatment is cost-effective.

What this could mean

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

Active substance
ozone gas
What this could lead to
If it works, this could offer a new, low-cost way to reduce chronic nerve pain in cancer survivors.
What could go wrong
This is a small, early-phase trial with only 42 participants. The effect may be small or no better than the placebo (oxygen).

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 42 people

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

Started

Nov 2020

Expected to finish

Dec 2027

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 to 100 years

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: * 1\. Adults \> = 18 years old. * 2\. Any kind of cancer in any stage, treated with any kind of chemotherapy, and life expectancy \> = 6 months. * 3\. Clinical diagnosis of painful chemotherapy-induced peripheral neuropathy, toxicity Grade 2 or higher according to the Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute of EEUU, v.5.0, for \> = 3 months and without the inclusion of new treatments for pain and/or neuropathy for \> = 1 month. * 4\. "Average pain" \> = 3/10 according to the Brief Pain Inventory-Short Form (BPI-SF) \> = 3 months beyond chemotherapy completion. * 5\. Pregnant women cannot participate in the clinical trial. * 6\. Before enrollment, women of childbearing potential should obtain a negative result in the serum or urine pregnancy test at the screening visit and accept the use of appropriate contraceptive methods at least from the 14 days prior to the first ozone therapy session up to 14 days after the last one. * 7\. Patients who have signed and dated the study 's specific informed consent Exclusion Criteria: * 1\. Age \< 18 years old. * 2\. Pregnancy at the time of enrollment. * 3\. Women with childbearing potential who are unwilling to perform a pregnancy test and/or employ adequate contraception from the 14 days prior to the first ozone therapy session up to 14 days after the last one. * 4\. Clinical suspicion that peripheral neuropathy (compressive or diabetic neuropathy) in the same area prior to receiving neurotoxic chemotherapy. * 5\. Psychiatric illness or social situations that would limit compliance with study requirements. * 6\. Those who are unable to fill in the scales used to measure quality of life variables * 7\. Specific liver enzymes \[Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) \> 5 times the upper limit of normal * 8\. Increased creatinine \> 3 times the upper limit of normal. * 9\. Hemodynamically or clinically unstable patients or uncontrolled severe illness. * 10\. Uncontrolled cancer disease. * 11\. Leptomeningeal carcinomatosis. * 12\. Life expectancy \< 6 months * 13\. Contraindication or disability for rectal ozone administration or to attend scheduled treatments. * 14\. Known allergy to ozone. * 15.Patients who do not meet all the inclusion criteria.

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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.

How to take part

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

  1. The places running it

    2 sites. 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

  • Complejo Hospitalario Materno Insular

    RECRUITING

    Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

  • Hospital Universitario de Gran Canaria Dr. Negrín

    RECRUITING

    Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

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