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Ozone Treatment for Numbness and Tingling from Chemotherapy in Patients with Peripheral Neuropathy: A Clinical Trial

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for paresthesia, which is a condition characterized by numbness and tingling. This condition can occur as a side effect of chemotherapy, known as chemotherapy-induced peripheral neuropathy. The trial will explore the use of a treatment involving ozone, a form of oxygen, to see if it can help reduce these symptoms and improve the quality of life for patients experiencing moderate to severe paresthesia.

The treatment involves using a mixture of ozone and oxygen, which is administered through a method called rectal insufflation. This means the gas mixture is introduced into the body through the rectum. The study aims to determine if adding ozone to the usual care for paresthesia can help patients feel better and improve their daily lives. The trial will also look at how this treatment affects patients' overall health and well-being over a period of time.

Participants in the study will receive the treatment over a period of 16 weeks, with follow-up assessments continuing for up to 28 weeks. The study will measure changes in the level of numbness and tingling that patients feel, as well as their overall quality of life. The goal is to find out if this new approach can offer a beneficial addition to the current management of paresthesia caused by chemotherapy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the trial's objectives and procedures.

    The participant will be required to sign a consent form to confirm understanding and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the participant's baseline condition.

    This assessment will include a self-reported evaluation of paresthesia (numbness, tingling) and quality of life using specific questionnaires.

  3. Step 3

    Ozone treatment

    The participant will receive ozone treatment administered rectally.

    The treatment will be conducted over a period of 16 weeks, with sessions scheduled according to the study protocol.

  4. Step 4

    Mid-treatment evaluation

    At the end of the ozone treatment period, a mid-treatment evaluation will be conducted.

    This evaluation will assess changes in paresthesia and quality of life, as well as any changes in anxiety and depression levels.

  5. Step 5

    Follow-up period

    Following the treatment phase, a follow-up period of 12 weeks will occur.

    During this time, the participant's condition will continue to be monitored, and additional assessments will be conducted.

  6. Step 6

    Final assessment

    At the end of the follow-up period, a final assessment will be conducted.

    This assessment will evaluate the overall changes in paresthesia, quality of life, and other health parameters from the baseline.

Who can join the trial?

8 criteria

  • Must be an adult, which means being **18 years old** or older.
  • Must have received **chemotherapy** treatment for any type of tumor in the past.
  • Must have a clinical diagnosis of **paresthesia**, which is a feeling of numbness or tingling, caused by **chemotherapy-induced peripheral neuropathy** (CIPN). The symptoms should be moderate or more severe and have lasted for at least **3 months**.
  • Must not have received any **neurotoxic chemotherapy** (chemotherapy that can harm the nerves) for at least **3 months**.
  • The cancer must be stable or in remission, meaning it is not currently growing or spreading.
  • Must have a **life expectancy** of at least **6 months**.
  • Women who can have children must have a negative pregnancy test before joining the study and agree to use effective birth control methods from **14 days** before the first ozone therapy session until **14 days** after the last session.
  • Must agree to participate by signing and dating the study's specific **informed consent** form, which explains the details of the study.

Who cannot join the trial?

5 criteria

  • Patients who do not have **paresthesia** (numbness or tingling) caused by **chemotherapy-induced neuropathy** cannot participate.
  • Patients with **paresthesia** that is less than **Grade 2** (mild symptoms) are not eligible.
  • Individuals who are not within the specified age range for the study cannot join.
  • Both male and female patients are eligible, so gender is not an exclusion factor.
  • Patients who are part of a vulnerable population are not excluded based on this criterion.
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Investigated drugs

Ozone Therapy is being studied for its potential benefits in patients experiencing paresthesia, which includes symptoms like numbness and tingling, as a result of chemotherapy-induced peripheral neuropathy. This therapy involves the administration of ozone, a form of oxygen, to see if it can improve the patients' perception of their symptoms and enhance their overall quality of life. The trial aims to determine if adding ozone therapy to the standard treatment can provide additional relief from these uncomfortable sensations.

What is already known about the treatment

Ozone Therapy – Ozone therapy is administered through various methods, including injections or insufflation, depending on the specific medical condition being treated. It is currently being studied in clinical trials for its potential benefits in managing paresthesia, which is numbness or tingling, secondary to chemotherapy-induced neuropathy. The main therapeutic indication for ozone therapy in this context is to alleviate symptoms of paresthesia and improve the quality of life for patients experiencing these symptoms due to chemotherapy. At the molecular level, ozone therapy is believed to enhance oxygen delivery to tissues and modulate the immune response, although the exact mechanism is still under investigation. It is classified under alternative and complementary medicine, with ongoing research to better understand its efficacy and safety in various medical conditions.

Investigated diseases

Chemotherapy-Induced Peripheral Neuropathy – This condition occurs as a side effect of certain chemotherapy drugs, leading to damage in the peripheral nerves. It often manifests as paresthesia, which includes sensations of numbness and tingling, primarily in the hands and feet. The symptoms can range from mild discomfort to severe pain and may affect daily activities. Over time, the condition can progress, causing more persistent and widespread symptoms. The severity of the neuropathy can vary depending on the type and dose of chemotherapy received. It is a common issue for cancer patients undergoing treatment, impacting their quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-517196-20-00Protocol codeOzoParQTEstimated enrolment42 patientsSponsorEl Hospital Universitario De Gran Canaria Dr. Negrin

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).