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Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy

NCT ID: NCT06706544
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2 / Phase 3
Sponsor: Bernardino Clavo, MD, PhD
Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN), Numbness, Paresthesia, Tingling

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Effectiveness and Cost-effectiveness of Ozone Treatment in Patients With Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (OzoParQT)

Enrollment: 42 participants (Estimated).

What is being studied

Intervention: Chalcogens
Intervention: Elements
Intervention: Gases
Intervention: Inorganic Chemicals
Intervention: Oxygen
Drug: Oxygen (placebo)
Drug: Ozone therapy

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 1\. Adults \> = 18 years old. * 2\. Previous treatment with any chemotherapy because of any tumor. * 3\. Clinical diagnosis of paresthesia (numbness, tingling) secondary to CIPN, with toxicity Grade \> = 2 (according to the Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute of EEUU, v.5.0) for \> = 3 months. * 4\. Without neurotoxic chemotherapy \> = 3 months. * 5\. Cancer disease is stable or in remission. * 6\. Life expectancy \> = 6 months. * 7\. 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 14 days before the first ozone therapy session up to 14 days after the last one. * 8\. To sign and date the study-specific informed consent Exclusion Criteria: * 1\. Age \< 18 years. * 2\. A woman who is lactating, pregnant, suspected of being pregnant, or a woman of childbearing potential who does not use adequate contraceptive methods. * 3\. Suspected symptoms are due to diabetic or compressive neuropathy. * 4\. Severe psychiatric disorders. * 5\. Inability to complete the quality of life questionnaires. * 6\. Elevation above 5 times the maximum limit of normal creatinine. * 7\. Patient who is hemodynamic or clinically unstable or who requires urgent or short-term interventional measures. * 8\. Neoplasia in progression requiring recent initiation of systemic treatment or maintenance with neurotoxic chemotherapy. * 9\. Life expectancy (for any reason) \< 6 months. * 10\. Known allergy to ozone, known glucose 6 phosphate dehydrogenase (G6PD) deficiency, or hemochromatosis. * 11\. Contraindications or impossibility for rectal ozone treatment or to attend regularly to the treatment. * 12\. Not meeting each and every one of the inclusion criteria

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Spain

Las Palmas, Spain: 1

Sample of listed locations

Dr. Negrín University Hospital — Las Palmas, Las Palmas, 35019, Spain — Recruiting

Study details

Start date: February 7, 2025
Primary completion date: December 31, 2029
Completion date: March 31, 2030
First posted: November 26, 2024
Collaborators: Centers for International Business Education and Research, Complejo Hospitalario Universitario Insular Materno Infantil, Council of Gran Canaria, Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Instituto de Salud Carlos III, Servicio Canario de Salud, University of Las Palmas de Gran Canaria

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06706544
Registry last updated: September 18, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT06706544 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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