Using ozone therapy to treat pain from chemotherapy-induced nerve damage
Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Pain Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (O3NPIQ)
This study is testing whether ozone therapy can help cancer patients who have ongoing pain from chemotherapy-induced nerve damage feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Dr. Negrin University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Las Palmas de Gran Canaria, Las Palmas and 1 other locations) |
| Trial ID | NCT04299893 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and cost-effectiveness of ozone therapy as an additional treatment for patients suffering from chemotherapy-induced peripheral neuropathy (CIPN). It is a randomized controlled trial involving 42 patients with cancer who have experienced persistent pain due to CIPN for at least three months. Participants will receive either ozone therapy or a placebo in conjunction with their usual treatment, and various health-related quality of life metrics will be assessed. The study also aims to explore the impact of ozone therapy on oxidative stress, chronic inflammation, and patient anxiety and depression.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with any type of cancer who have experienced moderate to severe pain from chemotherapy-induced peripheral neuropathy for at least three months.
Not a fit: Patients who are pregnant or have not completed chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from chemotherapy-induced peripheral neuropathy.
How similar studies have performed: While ozone therapy is a novel approach in this context, similar studies exploring complementary therapies for neuropathic pain have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Las Palmas de Gran Canaria, Las Palmas and 1 other locations
- 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)
Study contacts
- Principal investigator: Delvys Rodríguez-Abreu, MD — Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas, Spain
- Study coordinator: Bernardino Clavo, MD, PhD
- Email: bernardinoclavo@gmail.com
- Phone: (34)928449278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.