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Recruiting Phase 2/3

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

NCT04299893 · tracked via the Priya Life Science Spain tracker
Sponsor
Bernardino Clavo, MD, PhD
Phase
Phase 2/3
Started
2020-11-30
Last updated
2026-09-25

Condition(s) studied

Chemotherapy-induced Peripheral NeuropathyPain, NeuropathicPain Syndrome

Investigational drug(s) / intervention(s)

Ozone →Oxygen

Ozone: Ozone Group: Standard treatment + Ozone therapy (O3/O2) by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.

Oxygen: Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change from Baseline in "Average pain" according to the Brief Pain Inventory-Short Form (BPI-SF) (at the end of ozone therapy) — 16 weeks
    Self-reported evaluation of 15 items to assess the severity of pain on daily functions in seven interference areas. From the 15 items, 11 items are scored from 0 ("No pain" or "Does not no interfere") to 10 ("Pain as bad as you can imagine" or "Completely interferes").
  • Direct Hospital Cost (at the end of ozone therapy) — 16 weeks
    The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 16 weeks of ozone therapy (in euros).

Trial sites (2)

FacilityCityRegionStatus
Complejo Hospitalario Materno Insular Las Palmas de Gran Canaria Las Palmas Recruiting
Hospital Universitario de Gran Canaria Dr. Negrín Las Palmas de Gran Canaria Las Palmas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04299893 on ClinicalTrials.gov ↗ ← All trials in Spain