NCT04299893 Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ)
| NCT ID | NCT04299893 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Bernardino Clavo, MD, PhD |
| Condition | Chemotherapy-induced Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2020-11-30 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2020-11-30 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Bernardino Clavo, MD, PhD
STUDY CHAIR
Dr. Negrín University Hospital, Las Palmas, Spain
Frequently Asked Questions
Who can join the NCT04299893 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Chemotherapy-induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04299893 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04299893 currently recruiting?
Yes, NCT04299893 is actively recruiting participants. Contact the research team at bernardinoclavo@gmail.com for enrollment information.
Where is the NCT04299893 trial being conducted?
This trial is being conducted at Las Palmas de Gran Canaria, Spain, Las Palmas de Gran Canaria, Spain.
Who is sponsoring the NCT04299893 clinical trial?
NCT04299893 is sponsored by Bernardino Clavo, MD, PhD. The principal investigator is Bernardino Clavo, MD, PhD at Dr. Negrín University Hospital, Las Palmas, Spain. The trial plans to enroll 42 participants.