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 study about?

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.

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 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 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 biochemical and imaging tests

Biochemical tests are performed to measure oxidative stress and inflammation.

Hyperspectral imaging is used to examine the painful area.

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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
30.11.2020

Trial locations

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.

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 ID:
2024-518021-16-00
Protocol code:
O3NPIQ
Trial Phase:
Therapeutic use (Phase IV)

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