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Study on the Effectiveness of Ozone Therapy for Pain Relief in Cancer Patients with Chemotherapy-Induced Peripheral Neuropathy

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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 effectiveness of a treatment called Ozone therapy for patients experiencing pain due to chemotherapy-induced peripheral neuropathy. This condition is a type of nerve damage that can occur after chemotherapy, leading to pain and discomfort. The treatment being tested involves using a special mixture of gases, primarily made up of oxygen, with a small amount of ozone. The purpose of the study is to see if adding ozone therapy to the usual care can help reduce pain and improve the quality of life for these patients.

Participants in the study will receive either the ozone therapy or a placebo, which is a substance with no active therapeutic effect. The study is designed to be triple-blind, meaning that neither the participants, the healthcare providers, nor the researchers know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The treatment will be administered rectally, which means it is given through the rectum. The study will last for a period of time, during which participants will be monitored for changes in their pain levels and overall health.

The main goal is to assess how the addition of ozone therapy affects pain and self-perceived health-related quality of life. The study will also look at the cost-effectiveness of this treatment, meaning it will evaluate whether the benefits of the therapy justify the costs involved. Participants' quality of life will be measured using questionnaires, and other factors like anxiety, depression, and nerve function will also be assessed. The study aims to provide valuable information on whether ozone therapy can be a beneficial addition to the standard management of pain in patients with chemotherapy-induced peripheral neuropathy.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria such as age, cancer stage, and pain level.

    A negative pregnancy test is required for women of childbearing potential before starting the therapy.

  2. Step 2

    Ozone therapy sessions

    Ozone therapy is administered to assess its effect on pain and quality of life.

    The therapy involves the use of ozone, a form of oxygen, delivered rectally as a medicinal gas.

  3. Step 3

    Monitoring and assessments

    Regular assessments are conducted to monitor pain levels using the Brief Pain Inventory-Short Form (BPI-SF).

    Quality of life is evaluated through questionnaires such as EQ-5D-5L and SF-36v2.

  4. Step 4

    Biochemical and imaging tests

    Biochemical tests are performed to measure oxidative stress and inflammation.

    Hyperspectral imaging is used to examine the painful area.

  5. Step 5

    Psychological evaluations

    Levels of anxiety and depression are assessed using the Hamilton scale.

    Nerve conduction studies are conducted to evaluate nerve function in the painful area.

  6. Step 6

    Safety and acceptability

    The safety of rectal ozone therapy is monitored throughout the trial.

    The acceptability of a shared decision-making tool is evaluated among participants and professionals.

  7. Step 7

    Completion of the trial

    The trial is expected to conclude by December 31, 2027.

    Final assessments are conducted to determine the effectiveness and cost-effectiveness of the therapy.

Who can join the trial?

7 criteria

  • Must be an adult, which means being **18 years old or older**.
  • Must have **cancer** at any stage and be receiving **chemotherapy** treatment, with a life expectancy of more than **6 months**.
  • Must have a **clinical diagnosis** of painful **chemotherapy-induced peripheral neuropathy**. This means nerve pain caused by chemotherapy, with a severity level greater than **2** on a specific scale used by doctors, and it must have lasted for more than **3 months**. No new treatments for pain or neuropathy should have been started in the last **month**.
  • Must have an **average pain level** greater than **3 out of 10** on a pain scale for more than **3 months**.
  • Pregnant women are not allowed to participate in the clinical trial.
  • Women who can become pregnant must have a **negative pregnancy test** before joining the study and agree to use **birth control** methods from **14 days** before the first ozone therapy session until **14 days** after the last session.
  • Must have **signed and dated** the specific informed consent form for the study, which means agreeing to participate after understanding the details of the trial.

Who cannot join the trial?

7 criteria

  • Patients who have not experienced pain due to chemotherapy-induced peripheral neuropathy for more than 3 months.
  • Patients with a pain level less than Grade 2, which means the pain is not severe enough.
  • Patients who are not receiving standard management for their condition.
  • Patients who are not willing to try Ozone therapy as part of their treatment.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not within the specified age range for the study.
  • Patients who do not meet other specific health criteria set by the study organizers.
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Investigated drugs

Ozone Therapy is being studied for its potential to relieve pain in patients who have developed peripheral neuropathy as a side effect of chemotherapy. This therapy involves the use of ozone, a form of oxygen, which is thought to have anti-inflammatory and pain-relieving properties. The trial aims to determine if adding ozone therapy to the standard treatment can improve the quality of life for these patients.

What is already known about the treatment

Ozone Therapy – Ozone therapy is administered through various methods, including injections or insufflations, depending on the specific medical condition being treated. It is currently being studied in clinical trials for its effectiveness in managing pain associated with chemotherapy-induced peripheral neuropathy. The main therapeutic indication for ozone therapy in this context is to alleviate pain and improve the quality of life for patients undergoing cancer treatment. At the molecular level, ozone therapy is believed to work by modulating oxidative stress and enhancing oxygen metabolism, which may help reduce inflammation and pain. It is classified under alternative and complementary medicine, with ongoing research to better understand its potential benefits and cost-effectiveness in medical practice.

Investigated diseases

Chemotherapy-Induced Peripheral Neuropathy – This condition occurs as a side effect of certain chemotherapy drugs, leading to nerve damage. It primarily affects the peripheral nerves, which are responsible for transmitting signals between the central nervous system and the rest of the body. Patients may experience symptoms such as tingling, numbness, and pain, often starting in the hands and feet. The severity of symptoms can vary, and they may worsen with continued chemotherapy treatment. Over time, the condition can lead to difficulties in performing daily activities due to the discomfort and sensory changes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-518021-16-00Protocol codeO3NPIQEstimated enrolment42 patientsSponsorDr. Bernardino Clavo Varas

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