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NCT04299893From ClinicalTrials.govRecruiting

Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)

Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Pain Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (O3NPIQ)

  • Chemotherapy-induced Peripheral Neuropathy
  • Pain, Neuropathic
  • Pain Syndrome

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Bernardino Clavo, MD, PhD
Enrolment target
42
Started
30 November 2020
Main results due
30 September 2027
Study sites
2
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 100 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

The main objective of this clinical trial is to evaluate the effectiveness and cost-effectiveness of adding ozone therapy to the clinical management of patients with pain secondary to chemotherapy-induced peripheral neuropathy

Study sites(2)

  • Complejo Hospitalario Materno Insular

    Las Palmas de Gran Canaria, Las Palmas, Spain

    Recruiting

  • Hospital Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, Las Palmas, Spain

    Recruiting

Showing 2 of 2 sites. 2 of the 2 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04299893. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ) | Trialion